A Strategic and IP-Centric Analysis of the Cardiac Diagnostics Ecosystem

Authors: Tyler Teske, Will Rosellini

 

Highlights

• Cardiac Diagnostics Are at an Inflection Point. The tools once confined to hospitals are moving into everyday life, transforming how heart disease is detected, managed, and prevented.
• A $133 Billion Opportunity Remains Under-Diagnosed. Cardiovascular disease – the world’s leading cause of death – accounts for one in four U.S. deaths. Most cardiac events begin outside medical supervision, yet ischemia-detecting tools remain locked within hospitals – creating the largest unmet diagnostic gap in cardiovascular medicine.
• Three Landscapes Define the Race for Leadership. Consumer wearables dominate accessibility, ambulatory systems extend monitoring duration, and 12-lead clinical platforms define diagnostic gold standards – but none yet combine portability with ischemia detection.
• Consumer ECG – Accessibility Without Ischemia Detection. Apple, Samsung, Google, and Fitbit lead a global installed base exceeding 200 million devices with FDA-cleared single-lead ECGs for atrial fibrillation detection. Whoop, Oura, Withings, Garmin, Zepp, and Masimo follow with similar architectures. Despite massive adoption, every device remains single-lead – capable of rhythm screening, not ischemia diagnosis.
• Ambulatory ECG – Extended Duration Without Full Diagnosis. iRhythm, AliveCor, Bardy Diagnostics, Preventice, and BioTelemetry have built multi-billion-dollar markets around patch and handheld monitors recording up to 14 days of clinical-grade ECG. Yet all remain limited to six leads or fewer – capturing arrhythmias, not infarctions.
• Traditional 12-Lead ECG – Gold Standard, Zero Mobility. Philips, GE Healthcare, Medtronic, Nihon Kohden, and Schiller dominate institutional cardiology with hospital-based 12-lead systems that provide definitive ischemia and infarction diagnosis but require stationary infrastructure and trained technicians.
• HeartBeam Emerges as the Bridge. HeartBeam’s FDA-cleared, three-lead platform for arrhythmia assessment can be used to mathematically reconstruct a 12-lead equivalent from the heart’s electrical signals, captured in three distinct, non-coplanar directions. This unique configuration has the potential to enable a clinical-grade ischemia detection tool in credit-card-sized or patch form factors – offering the first credible pathway toward total cardiac intelligence.

 

1.0 Introduction

Cardiovascular disease remains the world’s leading cause of death and one of the most costly chronic conditions to manage. In the United States, roughly one in four deaths are attributed to heart disease. More than 30 million adults live with a diagnosed condition, 805,000 experience a heart attack each year, and nearly 12% of those events are fatal. Among survivors, approximately one in five suffer another cardiovascular event within the first year. Despite major advances in therapeutics, imaging, and interventional cardiology, the foundational problem of time to diagnosis persists – most cardiac events begin outside medical supervision, while diagnostic tools remain confined to clinical settings.

The purpose of this analysis is to examine the technological and clinical landscape of electrocardiography (ECG) systems – consumer wearables, ambulatory monitors, and traditional 12-lead platforms – to understand how innovations in mobility, sensor fidelity, and data interpretation could close that diagnostic gap.

Today’s cardiac diagnostic ecosystem operates at three disconnected layers:

1. Consumer devices deliver accessibility but limited diagnostic power, capturing basic rhythm irregularities through single-lead or optical sensors.
2. Ambulatory monitors extend monitoring duration but remain constrained by lead count and data fragmentation.
3. Clinical 12-lead systems provide the gold standard for ischemia and infarction detection but require professional setup and stationary infrastructure.

These divisions define both the opportunity and the necessity for progress. Heart disease often develops silently over time, yet its acute manifestations – heart attacks, arrhythmias, sudden cardiac arrest – demand immediate recognition. Reducing the interval between symptom onset and clinical intervention is the single most powerful determinant of survival and long-term recovery.

By mapping the evolution of ECG technology across these three tiers, this report seeks to clarify where current solutions fall short and how emerging approaches may enable earlier, more accurate, and more continuous cardiac assessment. The ultimate objective is to outline the scientific and market rationale for next-generation systems capable of delivering clinical-grade insights anywhere symptoms begin – bridging prevention, detection, and timely treatment into a unified continuum of cardiac care.

 

2.0 Executive Summary

Unlocking the Multi-Billion-Dollar Cardiac Intelligence Race

Cardiac diagnostics have reached a historic inflection point. The tools that once lived exclusively inside hospitals are moving into everyday life, transforming how heart disease is detected, managed, and prevented. The connected medical devices market – valued at $66 billion in 2024 and projected to reach $133 billion by 2029 (15% CAGR) – is expanding rapidly as clinical-grade monitoring merges with consumer technology. Yet despite this growth, a fundamental diagnostic gap persists: most cardiac events begin outside medical facilities, while the tools capable of detecting life-threatening ischemia remain confined to hospital walls.

 

The Capital Surge: Funding the Cardiac Monitoring Revolution

The sector is attracting extraordinary capital and commanding premium valuations across all three tiers of cardiac monitoring. Public companies in ambulatory monitoring trade at multi-billion-dollar valuations: iRhythm ($3.6B market cap), with major acquisitions including Philips’ $2.8B purchase of BioTelemetry and Boston Scientific’s $1.2B acquisition of Preventice Solutions validating the sector’s growth trajectory. Consumer wearable giants Apple, Samsung, and Google have integrated FDA-cleared ECG functionality into devices reaching hundreds of millions of users globally. Private challengers like Whoop (211 patent documents) and AliveCor ($154M raised) continue building IP estates spanning hardware, algorithms, and clinical integration. Traditional 12-lead incumbents – Philips and GE Healthcare maintain vast portfolios but face disruption from portable, continuous monitoring solutions.

 

The Competing Technologies: Four Signal Types Racing for Clinical Validation

Cardiac monitoring relies on four main signal acquisition technologies, each with distinct capabilities and limitations:

• Photoplethysmography (PPG): Uses optical sensors (LEDs and photodiodes) to track blood volume changes with each heartbeat by measuring light absorption through skin. Highly scalable for continuous, passive heart rate and rhythm screening. Deployed in virtually all consumer wearables for 24/7 monitoring without user intervention. Limited to rhythm detection – cannot diagnose ischemia, infarction, or most conduction abnormalities.
• Electrocardiography (ECG): Measures the heart’s electrical activity directly using skin electrodes that detect bio-potential signals generated by cardiac depolarization and repolarization. The 12-lead ECG remains the clinical gold standard, using ten electrodes to generate twelve electrical perspectives for comprehensive diagnosis of arrhythmias, ischemia, infarction, and conduction abnormalities. Single-lead consumer devices detect atrial fibrillation but lack spatial resolution for ischemia. Diagnostic capability scales directly with lead count – more leads provide more spatial information.
• Vectorcardiography (VECG): Maps the heart’s electrical forces in three dimensions (X, Y, Z axes), traditionally confined to research and limited clinical use due to complex electrode configurations.
• Emerging Three-Dimensional (3D): Captures the heart’s electrical forces from three non-coplanar directions. The technology basis is a ramification similar to Vectorcardiology (VECG). Recent advances now enable ambulatory, portable systems that derive three-dimensional spatial information from as few as five strategically placed electrodes. Mathematical reconstruction algorithms transform these 3-vectors into 12-lead-equivalent outputs, bringing potential clinical-grade ischemia detection tools outside traditional clinical environments for the first time.

 

The Competing Form Factors: Three Tiers, Three Trade-offs

The cardiac monitoring landscape operates across three disconnected tiers, each optimizing for different clinical and commercial priorities:

• Consumer Wearables (PPG + Single-Lead ECG): Smartwatches, fitness bands, and smart rings deliver unprecedented accessibility and continuous monitoring duration. Over 200 million wearable devices shipped globally in 2024, with FDA-cleared atrial fibrillation detection now standard in premium models. Devices require no professional setup and integrate seamlessly into daily life. Trade-off: Cannot detect myocardial ischemia or acute coronary syndromes – the leading cause of cardiac death.
• Ambulatory Monitors (1-Lead to 6-Lead ECG): Prescription medical devices including adhesive patches, event recorders, and mobile cardiac telemetry systems extend monitoring from days to weeks with clinical-grade signal quality. Enable comprehensive arrhythmia detection, symptom correlation, and rhythm analysis with established reimbursement pathways. Trade-off: Single- to six-lead configurations lack the spatial resolution required for ischemia detection. No ambulatory device with six or fewer leads claims myocardial infarction diagnosis.
• Traditional 12-Lead ECG Systems: Hospital-based electrocardiographs using ten electrodes positioned across chest and limbs generate twelve electrical perspectives – the reference standard for diagnosing acute coronary syndromes, localizing infarction territory, and guiding emergency intervention. Indispensable in emergency departments and catheterization labs worldwide. Trade-off: Requires professional electrode placement, stationary infrastructure, and captures only seconds of cardiac activity during scheduled appointments. Zero portability, zero continuous monitoring.

 

The Diagnostic Hierarchy: What Each Lead Configuration Can Detect

Clinical utility scales directly with lead count and signal acquisition method:

• PPG (Optical Sensors): Measures heart rate, heart rate variability, and basic rhythm irregularity screening. Cannot generate ECG waveforms or detect electrical abnormalities.
• Single-Lead ECG: Detects heart rate, atrial fibrillation, atrial flutter, some supraventricular tachycardias, and provides basic rhythm classification. Cannot localize ischemia or diagnose acute coronary syndromes
• Three-Lead ECG: Captures three electrical vectors that provide improved spatial information compared to single-lead systems. Can detect some rhythm abnormalities and basic conduction patterns but lacks the comprehensive spatial coverage required for reliable ischemia detection and coronary territory localization.
• Six-Lead ECG: Provides six frontal-plane perspectives (I, II, III, aVR, aVL, aVF) improving rhythm discrimination and enabling limited ischemia screening. Offers improved spatial context over single-lead and three-lead systems but lacks precordial (chest) lead information critical for anterior wall infarction detection and comprehensive ischemia localization.
• Twelve-Lead ECG: Ten electrodes generate twelve perspectives including six precordial leads, providing complete spatial coverage of the heart’s electrical field. The gold standard for diagnosing myocardial ischemia, acute myocardial infarction (STEMI/NSTEMI), unstable angina, conduction blocks, chamber hypertrophy, and electrolyte abnormalities with coronary territory localization. Required for emergency triage and intervention planning.

The 12-lead ECG remains the reference standard, capturing the full electrical activity of the heart across the widest diagnostic spectrum: heart rate and rhythm abnormalities, arrhythmias (atrial fibrillation, flutter, supraventricular and ventricular tachycardias, pauses, blocks), myocardial ischemia and acute coronary syndromes with precise coronary territory localization enabling immediate catheterization lab activation.

 

The Unmet Clinical Need: A $133 Billion Diagnostic Blind Spot

Despite decades of innovation across all three tiers, no portable system successfully delivers 12-lead-equivalent ischemia detection with continuous monitoring capability.

• Consumer wearables track hundreds of millions of heartbeats but miss life-threatening ST-segment elevations. 
• Ambulatory ECG record weeks of data but cannot diagnose the myocardial infarctions they’re monitoring through. 
• Hospital 12-leads provide definitive diagnosis but only capture seconds of activity after patients reach medical facilities – often hours after symptom onset when myocardial damage is already irreversible.

For acute myocardial infarction, every 30-minute delay in reperfusion therapy increases mortality risk by 7.5%. For sudden cardiac arrest, survival probability drops 10% per minute before defibrillation. For unstable angina, early detection prevents progression to full infarction in over 60% of cases. The diagnostic gap between where cardiac events begin (home, workplace, during activity) and where 12-lead diagnosis occurs (emergency departments) represents the single greatest opportunity in cardiovascular medicine.

 

The Race for Leadership: Three Landscapes, One Convergence Point

This report profiles 27 companies across consumer wearables, ambulatory monitoring, and traditional 12-lead systems. Leadership is concentrating where validated clinical performance, regulatory clearance, intellectual property depth, and commercial traction align.

 

Consumer Wearables – Accessibility Without Ischemia Detection

Consumer wearables deliver continuous monitoring and single-lead ECG in smartwatches, bands, and rings. These devices detect common arrhythmias such as atrial fibrillation but do not detect ischemia or acute myocardial infarction.

• Apple (133 patent publications, 39 families): Introduced the first FDA-cleared consumer ECG in 2018 and maintains the largest installed base through Apple Watch Series 10 and Ultra 2. Foundational patents cover crown-electrode architecture and user interface workflows. The single-lead configuration limits detection capabilities to atrial fibrillation screening.
• Samsung (242 patent publications, 101 families): Holds the largest cardiac-related patent portfolio among consumer brands. Galaxy Watch series integrates ECG with blood pressure estimation and automated band-tightening for improved signal fidelity. Despite strong innovation in multi-sensor fusion and machine learning, the system remains restricted to single-lead rhythm detection.
• Google/Fitbit (187 patent publications, Google, 148 docs Fitbit): Combined portfolio following 2021 acquisition enables PPG-to-ECG escalation workflows and AI-driven cloud analytics for cardiac event prediction. Pixel Watch integrates these technologies but relies on single-lead architecture that cannot detect ischemia.
• Whoop (211 patent publications, 45 families): Subscription-based fitness band emphasizing recovery analytics. Added ECG functionality in 2025 MG model, complementing extensive PPG and HRV sensing capabilities. ECG intellectual property protection remains minimal with only two patent families, and the device is limited to single-lead rhythm monitoring.
• Oura (204 patent publications, 90 families): Smart ring form factor optimized for sleep and recovery monitoring using infrared PPG sensors. Recently filed ECG patents (6 families) but no devices have received regulatory clearance. The ring’s compact form factor restricts electrode spacing, fundamentally limiting diagnostic potential beyond basic rhythm screening.
• Withings (27 patent publications, 11 families): Launched ScanWatch ECG in 2020 combining analog design with digital measurement. Holds the smallest cardiac IP portfolio among major consumer players, with several patent applications rejected over prior Samsung art, weakening its competitive position in ECG innovation.
• Garmin (17 patent publications, 10 families): Added ECG functionality to Fenix and Epix lines in 2023. Intellectual property focus remains on optical and motion sensing rather than cardiac diagnostics, making ECG a secondary feature rather than a clinical differentiator.
• Zepp Health/Amazfit (13 patent publications, 11 families): Produces affordable ECG-enabled smartwatches for global markets. Lacks FDA clearance in the United States and holds limited cardiac-specific intellectual property, constraining expansion into regulated segments.
• Masimo (25 patent publications, 4 families): Long-established leader in clinical-grade pulse oximetry entered consumer market with W1 Medical Watch. PPG and SpO₂ sensors offer clinical-level accuracy, but ECG capabilities remain single-lead and late to market compared to established consumer players.

Technological parity has been achieved across the consumer tier. All major players employ similar PPG arrays and single-lead ECG architectures, with differentiation now occurring through algorithms, AI interpretation, clinical integration, and ecosystem lock-in rather than fundamental sensor innovation. Despite widespread adoption reaching hundreds of millions of users, none of these devices can detect ischemia.

 

Ambulatory Monitoring – Extended Duration, Incomplete Diagnosis

Ambulatory monitors are prescription devices enabling continuous or event-triggered ECG monitoring for arrhythmia detection and symptom correlation. These systems cannot diagnose myocardial ischemia due to lead-count constraints.

• HeartBeam (82 patent publications, 15 families): Developing credit-card-sized ECG system capturing three non-coplanar electrical vectors through a resistive network, enabling 12-lead synthesis. Received FDA 510(k) clearance in 2024 of the three-lead ECG recording for arrhythmia assessment, with pending clearance for full 12-lead reconstruction. Currently an ambulatory company pursuing ischemia and acute coronary syndrome detection from a cable-free, portable form factor, directly addressing the diagnostic blind spot that limits all other ambulatory systems.
• iRhythm (211 patent publications, 10 families): Market leader in adhesive patch monitoring with $3.6 billion market capitalization. Zio XT provides 14-day continuous store-and-forward recording, while Zio AT enables real-time data transmission. Zio Watch adds PPG-based AFib screening to the product line. Despite commercial dominance and extensive validation studies, the system remains single-lead and cannot detect ischemia despite capturing two weeks of continuous cardiac data.
• AliveCor (251 patent publications, 62 families): Handheld and credit-card ECG devices represent the largest intellectual property portfolio in the ambulatory tier. KardiaMobile (1-lead), KardiaMobile 6L (six frontal leads), and Kardia 12L (full cable-based system) offer escalating diagnostic capabilities. AI algorithms enable 12-lead reconstruction from fewer inputs. However, portable devices max out at six leads – insufficient for reliable ischemia detection – while the 12-lead version requires cables and eliminates portability advantages.
• Bardy Diagnostics (384 patent publications, 92 families): Acquired by Baxter/Hillrom for $367 million in 2021. Developed CAM patch optimized for P-wave clarity through sternal electrode placement. Despite holding the largest ambulatory IP estate with extensive patents on adhesive form factors and signal processing, single-lead configuration limits diagnostic scope to arrhythmia detection without ischemia capability.
• Preventice Solutions (33 patent publications, 14 families): Acquired by Boston Scientific for $1.2 billion in 2021. BodyGuardian MCT platform provides mobile cardiac telemetry with cellular data transmission and clinician workflow integration. Operates with one to three leads and is designed exclusively for rhythm monitoring and arrhythmia detection.
• BioTelemetry (53 patent publications, 3 families): Acquired by Philips for $2.8 billion in 2020. ePatch and CardioNet MCT systems combine patch-based monitoring with 24/7 clinician-staffed interpretation centers. Despite integration into Philips’ hospital-to-home care strategy and operating one of the largest cardiac monitoring service platforms globally, systems employ only one to three leads and cannot diagnose ischemia.

 

Traditional 12-Lead Systems – Gold Standard, Zero Mobility

Traditional 12-lead ECG systems are hospital-based electrocardiographs using ten electrodes to generate twelve electrical perspectives. They provide the reference standard for ischemia and infarction diagnosis but require professional setup and stationary infrastructure.

• Philips (3,309 patent publications, 879 families): Holds the world’s largest cardiac intellectual property estate and dominates institutional cardiology through IntelliVue monitoring networks and PageWriter ECG systems. Acquisitions of BioTelemetry ($2.8 billion, 2020) and Cardiologs AI (2021) extended reach into ambulatory monitoring and automated interpretation. Portfolio includes 63 AI-related filings for rhythm classification and predictive analytics. Despite extensive innovation spanning decades, business model remains anchored to capital equipment sales and hospital procurement cycles rather than portable consumer solutions.
• GE Healthcare (1,041 patent publications, 479 families): MAC-series ECG systems and MUSE Enterprise software define hospital workflows for ECG data management globally. Edison AI platform automates rhythm classification and diagnostic decision support, supported by 30 recent AI-focused patents. Strategic efforts remain focused on digitizing the existing installed base and embedding AI into institutional systems rather than developing portable 12-lead solutions for consumer or ambulatory markets.
• Nihon Kohden (519 patent publications, 206 families): Cardiofax and Life Scope systems represent Japanese institutional standard for hospital ECG and bedside monitoring. Strong signal-processing intellectual property reflects hardware engineering excellence. Only three AI-related patents filed between 2021-2024, indicating hardware-centric rather than digital transformation strategy with minimal cloud or predictive analytics development.
• Schiller AG (41 patent publications, 15 families): Swiss precision ECG manufacturer producing CARDIOVIT systems emphasizing signal quality and technical accuracy. Zero AI patents across entire portfolio, remaining focused purely on hardware manufacturing with no evident movement toward portable devices, cloud connectivity, or algorithmic interpretation platforms.

Institutional incumbents continue refining existing technologies but demonstrate limited appetite for disruptive mobility solutions. Recent acquisitions – Philips purchasing BioTelemetry and Boston Scientific acquiring Preventice – have extended enterprise reach into ambulatory monitoring markets. However, the tiers remain fundamentally separated: hospital systems stay stationary, ambulatory systems stay sub-12-lead, and consumer wearables remain single-lead. No traditional incumbent has bridged the diagnostic gap between institutional infrastructure and portable ischemia detection.

 

The Convergence Opportunity: Who Will Close the Diagnostic Gap?

Four distinct technological and commercial trajectories are racing toward the same unmet clinical need:

• Consumer wearables could add more electrodes and leads to achieve ischemia detection capability. However, wrist-worn and finger-worn form factors face fundamental geometric constraints – true 12-lead measurement requires chest electrode placement and spatial separation that cannot be achieved in watch or ring designs without complete product architecture redesign.
• Ambulatory monitors could increase lead count to enable ischemia detection. However, cable-free ECG limitations prevent achieving the spatial resolution of hospital 12-lead systems, while adding cables eliminates the portability and patient compliance advantages that define the category’s commercial success and differentiation from hospital systems.
• Traditional 12-lead manufacturers could miniaturize existing systems for portable deployment. However, decades of capital-equipment business models, hospital procurement cycles averaging 8-10 years, and complete absence of direct-to-consumer distribution channels limit commercial agility and appetite for disruptive innovation outside institutional markets.
• Three-Dimensional (3D) represents the most promising pathway to bridge this gap: three directional vectors captured from strategically placed electrodes can mathematically reconstruct 12-lead-equivalent outputs – delivering clinical-grade ischemia detection in credit-card or patch form factors without cables. HeartBeam is the only company with FDA clearance of their three-lead platform that shows promise for this approach. No consumer wearable manufacturer, ambulatory monitoring incumbent, or traditional 12-lead system producer has publicly committed to a platform strategy or filed substantial intellectual property in 3D ECG technology.

This report maps the competitive landscape, evaluates intellectual property positioning, and assesses which companies and technologies are closest to bridging the divide that has defined cardiac diagnostics for five decades.

 

3.0 Consumer Wearable Cardiac Monitoring

Wearables are smart devices embedded with sensors and communication technology that collect, transmit, and sometimes analyze health-related data in real time. They are typically worn on the wrist, chest, or fingers. Common examples include smartwatches (e.g., Apple Watch, Samsung Galaxy Watch), fitness trackers (e.g., Fitbit, Garmin), and smart rings (e.g., Oura Ring). These devices use motion and biometric sensors to capture several physiologic parameters including step count, activity intensity, heart rate, heart rhythm, blood pressure, oxygen saturation, sleep quality, maximum oxygen uptake, and temperature. Consumer wearables have multiple potential clinical applications to enhance the screening and management of cardiovascular conditions.

 

Evolution of Cardiac Monitoring in Wearables

The integration of photoplethysmography (PPG) and electrocardiography (ECG) into smartwatches has transformed them from simple fitness trackers into validated medical devices capable of heart rhythm and arrhythmia detection. The development can be traced as a multi-stage evolution across the past two decades.

Early PPG Adoption (2009–2014): Early pulse-sensing smart devices used optical PPG sensors to track blood flow changes under the skin. PPG was first applied in wristbands for step counting and basic heart rate estimation between 2009 and 2010. The first generation of smartwatches with PPG-based heart rate tracking debuted in 2013–2014, led by Samsung Gear Fit and Basis B1 Band, which used green LEDs to measure continuous pulse rate through light absorption variations. PPG then became the standard for optical heart rate monitoring, spreading rapidly to Apple, Fitbit, Garmin, and Huawei devices.

Arrival of ECG Functionality (2018–2020): 2018 marked a landmark year when the Apple Watch Series 4 introduced the world’s first FDA-cleared single-lead ECG in a consumer smartwatch. It allowed users to record 30-second ECGs and detect atrial fibrillation (AFib) using embedded electrodes on the back crystal and digital crown. In 2019, companies like Withings (Move ECG) and AliveCor (KardiaMobile) brought similar medical-grade ECG detection capabilities, showing that single-lead consumer devices could achieve over 90% accuracy in AFib classification relative to 12-lead standards. The Apple Heart Study (2019) – involving over 400,000 participants – validated the irregular rhythm notification feature via PPG as an effective pre-screening tool for AFib.

Dual PPG + ECG Integration (2020–2023): Between 2020 and 2021, Withings ScanWatch and Fitbit Sense combined continuous PPG monitoring with on-demand ECG capability, merging passive rhythm surveillance with clinical-grade diagnostic snapshots.

Modern Era of Wearable Cardiac Analytics (2024–2025): By 2024, most premium watches (Apple Watch Series 9, Samsung Galaxy Watch 7, Withings ScanWatch 2) offered multi-sensor architecture – using simultaneous PPG for real-time heart rate and rhythm trend detection, and ECG for episodic arrhythmia confirmation.

PPG-enabled smartwatches made continuous heart-rate monitoring accessible, while ECG integration elevated them to medical-grade rhythm detectors. Together, they now enable end-to-end cardiac analytics – from passive pulse tracking to clinical arrhythmia detection- directly from the wrist.

 

Sensor Technologies for Cardiac Monitoring

Consumer wearable devices employ two primary sensor technologies for cardiac monitoring, each with distinct capabilities and clinical applications:

• Optical Heart Rate (PPG) Sensors: Optical heart rate sensors utilize photoplethysmography (PPG) technology, measuring blood volume changes beneath the skin through reflected light from LEDs. These sensors provide continuous tracking of heart rate (BPM) and heart rate variability (HRV), making them well-suited for fitness and wellness monitoring during workouts. PPG sensors enable continuous measurement without requiring user intervention.
• Electrocardiogram (ECG) Sensors:ECG sensors record the electrical activity of the heart through electrodes, capturing heart rhythm data that enables detection of arrhythmias such as atrial fibrillation. Unlike PPG sensors, ECG technology provides the diagnostic depth necessary for medical-grade rhythm analysis and AFib detection, though it typically requires deliberate user activation rather than continuous monitoring.

 

Implementation Across Form Factors

Smartwatches integrate both sensor types in wrist-worn devices. They employ optical PPG sensors – arrays of green or infrared LEDs and photodiodes positioned on the watch underside – for continuous heart-rate monitoring. Many models incorporate ECG electrodes, with one electrode on the back crystal and another on the crown or bezel, enabling single-lead ECG recordings when users complete the circuit with their opposite hand. This configuration enables rhythm characterization and basic arrhythmia detection.

Fitness bands represent simplified wrist-worn devices optimized for continuous motion and wellness tracking rather than diagnostic precision. They rely primarily on embedded PPG modules for heart-rate measurement. Some advanced designs include small conductive pads at each end to enable brief single-lead ECG recordings, though reduced electrode spacing and motion noise typically limit signal quality compared with smartwatches.

Smart rings represent the most compact form factor. Worn around the finger, they position miniaturized infrared and red LEDs along the inner circumference to record PPG signals from digital arteries, enabling accurate heart-rate and HRV tracking during sleep or rest. A few experimental models add dual-surface electrodes – one inner, one outer – to approximate a single-lead ECG when the opposite hand touches the outer ring.

 

Clinical Applications

The distinction between heart rate, heart rhythm, and arrhythmia detection is critical for understanding sensor capabilities:

• Heart Rate: The number of heartbeats per minute, measured effectively by both PPG and ECG sensors
• Heart Rhythm: The pattern and timing of heartbeats, requiring ECG technology to capture the heart’s electrical activity over time
• Arrhythmia Detection: Identification of specific rhythm abnormalities including atrial fibrillation (rapid, disorganized atrial signals), bradycardia (slower-than-normal rhythm below 60 BPM at rest), tachycardia (faster-than-normal rhythm exceeding 100 BPM at rest), and ventricular arrhythmias (potentially life-threatening abnormal rhythms originating in the ventricles)

The primary limitation of current consumer wearables lies in lead count. Single-lead or few-lead devices provide limited diagnostic information compared to the clinical standard 12-lead ECG, restricting their utility primarily to arrhythmia detection rather than comprehensive cardiac diagnosis.

 

Competitive Landscape

Despite these technological advances, the consumer cardiac wearable market has entered a period of technological convergence. Most devices now employ similar sensor architectures – optical PPG arrays for continuous monitoring and single-lead ECG electrodes for rhythm confirmation – resulting in overlapping technical capabilities and extensive prior art. Hardware differentiation has narrowed, and defensibility increasingly depends on algorithmic sophistication, signal quality, regulatory validation, and integration with clinical data ecosystems.

 

Analytical Framework

For each company, PatentVest conducted a standardized evaluation across four dimensions relevant to cardiac monitoring and IP defensibility:

• Product Offering: Devices and features specifically related to cardiac monitoring, including sensor modality (PPG, ECG), form factor (watch, band, ring), and intended use.
• Diagnostic Capability: The functional scope of cardiac assessment – continuous heart-rate and rhythm tracking via PPG, and arrhythmia or atrial fibrillation detection enabled by single-lead ECG.
• Clinical and Regulatory Milestones: Status of FDA or CE clearance, medical-device classification, and validation studies supporting diagnostic claims.
• Intellectual Property Portfolio: Patent coverage focused on cardiac sensing and analysis, including portfolio size, ECG-specific filings, and the foundational patent families defining each company’s core invention.

This framework enables an apples-to-apples comparison of how each manufacturer’s technology, clinical positioning, and IP strategy contribute to competitive differentiation within the cardiac wearables market.

 

Cardiac Patent Portfolios – Consumer Wearable Landscape

Total cardiac related patents per company. 

 

ECG-Specific Patent Porfolios – Consumer Wearables

Subset focused on electrocardiographic sensing and analysis

Apple

Apple Inc., a public company located in Cupertino, CA, produces the Apple Watch, which includes an ECG functionality. The Apple Watch is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect some common cardiac arrhythmias, such as atrial fibrillation. The Apple Watch, first introduced in 2015, pioneered photoplethysmography (PPG) for continuous heart rate monitoring using optical sensors on the underside of the watch to detect blood volume changes in the wrist, tracking heart rate, heart rate variability, and activity metrics in real time. In 2018, Apple Watch Series 4 became the first consumer smartwatch with an FDA-cleared single-lead ECG feature. This involved a new electrical sensor design, where users could record a 30-second ECG by touching the Digital Crown, completing an electrical circuit between electrodes on the crown and the back crystal. The ECG function enables users to detect potentially serious arrhythmias such as atrial fibrillation (AFib), with results documentable for physician review. These features are available on current models including Apple Watch Series 10 and Apple Watch Ultra 2.

Apple’s patent portfolio covering smartwatches with PPG/ECG for cardiac monitoring includes 39 patent families and 133 global patent publications with priority dates beginning in 2013 and latest filings in 2025. ECG-related patents specifically include 22 patent families and 90 publications, with the first publication in 2017.

Apple’s largest and foundational patent family covering their watch and ECG capability, which includes granted patent US11432766B2, covers an electronic watch with two electrodes for recording a single-lead ECG and the method for recording and displaying the ECG on the watch screen. With a priority date of 2018, Apple has expanded this family to more than eight jurisdictions, with numerous continuations bringing the total to 34 family members. The patent protects an electronic watch comprising a housing (the main body), a crown (the side knob that can be touched or turned), a transparent back glass (the rear surface that rests on the wrist), electrodes (metal contacts that detect heart signals), a processor (the chip that reads and processes those signals), and a display (the screen that shows the ECG waveform). The invention includes two electrodes that detect the heart’s electrical signals to record an electrocardiogram (ECG). One electrode is located on the back of the watch and remains in continuous contact with the wrist, while the second electrode is located on the crown, which is touched by the opposite hand during measurement. When both electrodes are in contact, they form a closed circuit through the body, allowing the watch to detect and record the heart’s electrical activity as a single-lead ECG. Apple had to narrow the claims after the examiner rejected the initial claims citing US20150041289A1, a previous Apple patent covering a smartwatch with ECG capability using a crown electrode and wrist contact to measure voltages and derive ECG signals, and US20170181644A1, a Motorola patent application covering a wearable device heart monitor system.

Additional smartwatch ECG patents include US10942491B2, which covers an electronic watch configured to measure heart rate using an optical sensor. Further, the electronic watch is configured to measure an electrocardiogram (ECG) using the first and second electrodes. An additional patent, US10973285B2, covers the watch housing, which includes a sensor configured to detect electrocardiographic (ECG) characteristics of a user, wherein the rear cover includes an electrode operably connected to the sensor. US granted patent, US11950916B2, covers user interfaces for health monitoring. The patent protects Apple’s ECG recording workflow, describing how the watch’s software detects stable contact, begins recording automatically, manages user feedback through changing on-screen interfaces, and displays or saves the ECG waveform once complete. This invention is further protected by two families including US11950916B2 and AU2019100222B4. 

Samsung

Samsung Electronics, a public multinational corporation based in Seoul, South Korea, produces the Galaxy Watch series, which includes ECG functionality. The Galaxy Watch is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect cardiac arrhythmias such as atrial fibrillation. Samsung integrated PPG-based heart rate monitoring into its early Galaxy and Gear smartwatch lines during the mid-2010s, using optical sensors for continuous heart rate, heart rate variability, and activity tracking. In 2019, the company introduced ECG functionality with the Galaxy Watch Active2 in South Korea, later expanding globally with the Galaxy Watch3 in 2020. The ECG feature requires activation through the Samsung Health Monitor app following regulatory approval in each market. Users record a 30-second ECG by touching the side button with the opposite hand, completing an electrical circuit between the button electrode and the back sensor. The ECG function enables detection of atrial fibrillation and sinus rhythm, with additional capabilities including ectopic beat detection and blood pressure estimation in select regions. These features are available on current models including Galaxy Watch8 series, Galaxy Watch7, and Galaxy Watch Ultra.

Samsung’s patent portfolio covering smartwatches and biosignal monitoring devices with PPG/ECG functionality for cardiac and physiological monitoring includes 101 patent families and 242 publications, with priority dates beginning in 2003 and latest filings in 2025. The portfolio encompasses ECG, PPG, blood pressure, and related physiological sensing technologies across wearable and portable form factors, primarily watches. ECG-related patents specifically include 64 patent families and 149 publications, with the first publication in 2003

Samsung’s foundational patent family covering its smartwatch and biosignal monitoring capability includes granted patent US10517182B2, which covers a wearable electronic device comprising a main body, a wearing unit configured to secure the device to the user’s body, and a driving mechanism that automatically adjusts the band’s fit. With a priority date of 2015, Samsung has expanded this family to 13 jurisdictions. The patent protects a wearable device comprising a main body (housing the electronics and sensors), a first wearing member (a strap section extending from the main body), a binding member (a movable band portion), and a driving member (a wire-based actuator that contracts to move the binding member and tighten the strap). The invention enables automatic tightening of the wristband to improve skin contact between the device and the user’s body, ensuring stable measurement of biometric signals. The main body includes a biometric signal sensor positioned on the inner surface to detect blood pressure, electrocardiogram (ECG), heart rate, heart rate variability (HRV), photoplethysmography (PPG), oxygen saturation, and other physiological parameters. The patent was initially rejected by the examiner citing US20170119314A1, assigned to Yukka Magic LLC, in a non-final and final rejection letter. Samsung added an intermediate linkage system connecting the wire to the movable strap, specified that the wire contracts when an electric signal is applied, and clarified the biometric sensor’s skin-facing placement.

Additional patents include US2020205732A1, which covers a clip-based ECG sensor attachment designed to couple with a wearable electrocardiogram unit. WO2022191413A1 discloses a multi-sensor wearable platform that applies machine-learning algorithms to improve heart-rate estimation accuracy under motion or low-signal conditions. Pending patent US2025082250A1 covers a multi-sensor atrial-fibrillation detection system combining PPG and motion sensing for continuous monitoring.

Google

Google LLC, a subsidiary of Alphabet Inc. (NASDAQ: GOOG) headquartered in Mountain View, California, produces the Pixel Watch, which includes ECG functionality inherited from its 2021 acquisition of Fitbit. The Pixel Watch is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect atrial fibrillation. Google entered the smartwatch market with the first-generation Pixel Watch launched in 2022, incorporating PPG-based heart rate and rhythm tracking from Fitbit’s established sensor technology for continuous monitoring of heart rate, heart rate variability, and activity metrics. ECG functionality was added shortly after launch, positioning the device as both a fitness tracker and medical monitoring tool. Users record a 30-second ECG by touching the Digital Crown with the opposite hand, completing an electrical circuit between the crown electrode and the bottom sensor, with results processed through the Fitbit app. The ECG function enables AFib detection with results documentable for physician review. These features are available on the current Pixel Watch 4.

Google’s patent portfolio covering smartwatches and cardiac monitoring technology includes 16 patent families and 39 publications, with priority dates beginning in 2018 and the latest filings in 2025, spanning five jurisdictions.  Google’s patent portfolio covers the watch form factor design, AI-driven cardiac event detection, machine-learning model for predicting cardiac dysfunction, and multi-module PPG/ECG wearables. ECG-related patents specifically include 6 families and 17 publications, also spanning 2018–2025 across five jurisdictions.

Google’s largest and foundational patent family (US2019159676A1) covers a wearable cardiac monitoring device equipped with two electrical contacts, a controller, a transceiver, and a user interface that together enable continuous arrhythmia detection and remote analysis. The wearable captures physiological signals locally, transmits them to a cloud-based classifier for interpretation, and then updates its onboard model with the refined classification data.

Additional patents including US2019159676A1 and US2021052229A1 cover systems for continuous arrhythmia detection and event classification using wearable sensors and cloud-resident analysis. Additionally, patent application US2025000459A1 protects AI-based models that analyze PPG and ECG data to predict cardiac dysfunctions, including low ejection fraction. The pending application further covers a wearable computing device configured with one or more PPG sensors to capture cardiac rhythm data and transmit those signals to remote computing systems for analysis, with claims also including integrated ECG sensors for obtaining an electrocardiogram.

Fitbit

Fitbit, founded in San Francisco and acquired by Google (Alphabet Inc.) in 2021, produces wearable fitness trackers and smartwatches with ECG functionality. The Fitbit Sense is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect atrial fibrillation. Fitbit pioneered consumer heart rate tracking with its Charge HR and Surge models in 2015, making PPG-based continuous heart monitoring accessible in affordable fitness bands using optical sensors to track heart rate, heart rate variability, and activity metrics in real time. The company introduced its first ECG-enabled device – the Fitbit Sense – in 2020 after securing FDA clearance, marking Fitbit’s evolution from fitness tracking into medical-grade cardiac monitoring. Users record a 30-second ECG using stainless steel ring electrodes on the watch case by touching the bezel with the opposite hand, completing an electrical circuit. In 2022, Fitbit launched a passive PPG-based irregular rhythm notification algorithm across multiple devices, enabling AFib screening without requiring manual ECG recordings. The ECG function classifies results as atrial fibrillation, normal sinus rhythm, or inconclusive, with exportable traces for clinical review. These features are available on current models including Charge 6, Sense 2, and Versa 4.

According to PatentVest, Fitbit Inc.’s patent portfolio covering smartwatches and cardiac monitoring technology includes 40 patent families and 148 publications, with priority dates beginning in 2013 and the latest filings in 2025, spanning seven jurisdictions.  These patents cover wearable form factors and fitness monitoring devices and a broad range of  signal processing methods, and health-tracking algorithms, including PPG, ECG, blood pressure, sleep, and motion sensing. ECG-related patents specifically include 13 families and 45 publications, filed between 2013 and 2025 across six jurisdictions. These patents cover wearable form factors with ECG electrodes and methods for characterizing cardiac arrhythmias.

Fitbit’s largest and foundational cardiac patent family, US8948832B2, covers a wearable fitness monitoring device including a motion sensor and a photoplethysmographic (PPG) sensor. The patent has over 18 family members and a priority date of 2012. ECG patents in Fitbit’s portfolio include US10398381B1, which covers on arrhythmia detection via PPG. It uses motion sensors to isolate low-motion intervals, captures high-quality PPG segments, and if irregular rhythm patterns are detected, it prompts the user to perform an ECG measurement. US2023240583A1 covers a multi-lead and single lead wearable device form factor, comprising both single-lead and multi-lead ECG. The design places three isolated electrodes on different surfaces of the device (top, bottom, side), enabling the system to verify contact quality and prompt the user to form proper electrode contact for accurate ECG acquisition.

Withings

Withings, a private French company headquartered in Issy-les-Moulineaux, produces the ScanWatch series, which includes ECG functionality. The ScanWatch is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect atrial fibrillation and other arrhythmias. Withings introduced continuous optical PPG monitoring with the Steel HR in 2016, embedding heart rate sensors into a hybrid analog-digital watch design for continuous tracking of heart rate, heart rate variability, and activity metrics. The company advanced into medical-grade cardiac monitoring with the ScanWatch in 2020, integrating single-lead ECG after securing CE approval in Europe, with FDA clearance following in 2021. Users record a 30-second ECG by touching side electrodes with the opposite hand, completing an electrical circuit. The PPG-based irregular rhythm detection prompts users to record confirmatory ECG when irregularities are detected. The ECG function enables AFib and arrhythmia screening with trace export for physician review, and recent models offer optional remote cardiologist ECG review services within 24 hours. These features are available on the current ScanWatch 2.

According to PatentVest, Withings patent portfolio covering smartwatches covering ecg/ppg includes 11 patent families and 27 publications, with priority dates beginning in 2019 and the latest filings in 2025, spanning four jurisdictions. ECG-related patents specifically include 8 families and 21 publications, filed between 2019 and 2025 across four jurisdictions. 

Withing’s largest patent family includes a US pending patent (US20230048160A1) that covers a portable electronic device, more specifically a connected watch, configured to be positioned on a users wrist, the portable device being configured to perform an electrocardiogram. The claims state that the watch includes two ECG electrodes. The first electrode is placed on the case back, maintaining continuous contact with the wrist. The second electrode is positioned on the rotatable bezel. When the user touches the bezel with the opposite hand, an electrical circuit closes through the body, allowing the ECG module inside the watch to capture and process cardiac signals. The pending patent has received multiple rejections and has been cited as lacking novelty from the examiner. In one non-final rejection letter, the examiner rejected pending claim 1 citing a Samsung patent (US20210186420A1), which covers a wearable electronic device for recording an ECG.

An additional pending patent protecting the connected ECG watch include US20240130679A1, which covers connected smartway for positioning on a user’s wrist, for performing an electrocardiogram. One new WO pending patent (WO2024194199A1), published in 2025, covers a computer program and algorithm for analyzing ECGs collected from a connected watch.

Masimo

Masimo Corporation (NASDAQ: MASI), a publicly traded medical technology company headquartered in Irvine, California, produces the W1 Medical Watch, which includes ECG functionality. The W1 Medical Watch is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect atrial fibrillation and arrhythmias. Masimo, recognized for clinical-grade pulse oximetry and patient monitoring systems, entered the consumer wearable market with the W1 Medical Watch in 2022, leveraging clinical-grade PPG technology originally developed for intensive care environments to provide continuous monitoring of SpO2, pulse rate, respiratory rate, and heart rate variability. An integrated ECG feature became available following FDA 510(k) clearance in 2023, enabling both prescription and over-the-counter use for arrhythmia screening. Users record a 30-second ECG using integrated electrode pads by touching the designated sensor area with the opposite hand, completing an electrical circuit. The ECG function enables AFib screening with detailed cardiac parameters including heart rate, HRV, and rhythm analysis, with connectivity to the Masimo SafetyNet platform for clinician oversight and remote patient monitoring.

According to PatentVest, Masimo’s patent portfolio covering wearable biosensing technologies related to cardiac includes 4 patent families and 25 publications from 2021 to 2025, spanning 8 jurisdictions. Masimo’s foundational granted patent (US12114974B2) with over 19 families members covers a wrist-worn health-monitoring watch built around a multi-emitter optical sensor for continuous measurement of physiological parameters such as oxygen saturation (SpO₂), while also enabling integration of ECG functionality. One pending patent published in 2025, US20250295366A1, covers a wearable system that continuously monitors SpO₂ and pulse rate (PR) using an optical sensor and flags likely respiratory events (depression, obstruction, apnea) by detecting deviations from personal baselines and computing a confidence score from SpO₂–PR correlation. It also measures other physiological parameters, including heart rate, heart rate variability, and electrocardiogram (ECG), as part of its multi-sensor monitoring platform.

Oura

Oura Health Oy, a private Finnish company headquartered in Oulu, produces the Oura Ring. The Oura Ring is a finger-worn smart ring that uses PPG sensors exclusively for biometric tracking and wellness insights. Oura pioneered the smart ring form factor with its first consumer ring in 2018, deploying multi-channel PPG sensors optimized for nighttime monitoring and recovery tracking using infrared and red LEDs positioned around the inner ring circumference to detect blood volume changes in the finger. The current Oura Gen3, launched in 2021, features upgraded infrared PPG sensors providing higher-fidelity continuous passive measurement of heart rate, heart rate variability, respiratory rate, and temperature during sleep and rest. Not FDA-cleared for AFib detection or arrhythmia diagnosis. 

Oura’s patent portfolio covering cardiac and heart-related sensing technologies includes 204 publications and 90 patent families, with priority dates beginning in 2015 and the latest filings in 2025, spanning eight jurisdictions. ECG related patents include 6 families and 19 publications. Oura’s foundational and largest patent family (US9582034B2) with over 101 family members covers a wearable computing device (WCD) in the form of a ring that can be worn on the finger of a human user. A recent pending family member (US20250231584A1), filed in 2025, covers the ring configured to is configured to perform one or more electrocardiogram (ECG) measurements. Additional ECG patents include US10884455B2, which covers an intelligent ring for ECG acquisition and wireless communication. US10842429B2 covers ring with two electrodes to measure an electrocardiogram Pending patent (US20230165508A1) covers methods, systems, and wearable devices for detecting atrial fibrillation (AFib). The patent covers a method for detecting atrial fibrillation with a ring that uses PPG (optical pulse) data. If the PPG-based algorithm flags a possible AFib event, the user is prompted to perform a confirmatory ECG measurement using electrodes built into the ring – one on the inner surface touching the skin and another on the outer surface touched by the opposite hand.

Whoop

Whoop Inc., a private Boston-based company, produces the Whoop band series, with ECG functionality added in the latest Whoop MG model. The Whoop MG is a single-lead ECG with two electrodes that contact the wrist and the finger and is intended to detect atrial fibrillation and arrhythmias. Whoop launched in 2015 with the Whoop 1.0, a PPG-based fitness band focused on continuous heart rate analytics for athletic performance and recovery optimization using a five-LED, four-photodiode optical sensor array to track heart rate, heart rate variability, respiratory rate, and skin temperature in real time. The company maintained a subscription-based model offering advanced recovery, strain, and sleep metrics derived from continuous PPG monitoring. In May 2025, Whoop introduced the Whoop MG – its first device with integrated ECG capability – expanding from performance tracking into arrhythmia detection. Users record an ECG by placing finger and thumb on electrodes embedded in the strap clasp, completing an electrical circuit. The ECG function enables AFib and arrhythmia detection, though as of October 2025, the company does not claim FDA clearance for AFib diagnosis. These features are available on current models Whoop 5.0 and Whoop MG.

According to PatentVest, since 2014, Whoop has built a portfolio of 45 patent families totaling 211 documents, with the most recent publication in 2025.  Portfolio covers signal acquisition via PPG and ECG sensors in a strap form factor, algorithms, software. 114 patent publications and 25 families cover the form factor, software, AI and PPG sensors for heart rate data collection. Only one patent family covers ECG. Whoops largest and earliest patent family, (US10264982B2), includes over 19 publications with a priority date September 2012.  Covers physiological measurement systems, devices and methods for continuous heart rate monitoring. Broadly covers PPG sensors for continuous heart rate capture embedded on a strap form factor. Early family members experienced many rejections. Significant prior art related to PPG for heart rate signal capture on wearable devices. Whoops pending patent related to ECG capabilities includes (US20250049334A1). It covers a wearable monitor for ECG that a first electrode for forming an electrocardiography circuit. A second electrode may be integrated into a removable strap or the like that secures the monitor in place during use.

Garmin

Garmin Ltd. (NASDAQ: GRMN), a global public company based in Switzerland and the US, produces smartwatches with ECG functionality in select models. Garmin watches with ECG are single-lead devices with two electrodes that contact the wrist and the finger and are intended to detect atrial fibrillation. Garmin integrated continuous heart rate monitoring into its Forerunner 225 in 2015 using the company’s proprietary Elevate PPG technology, initially targeting endurance athletes and outdoor fitness enthusiasts with optical sensors for continuous tracking of heart rate, heart rate variability, pulse oximetry, and respiration. Garmin introduced ECG recording capability for select models – including Fenix 7 Pro, Epix Pro, and Venu 3 – beginning in early 2023 through software updates and app integrations. Users record a 30-second ECG via wrist contact electrodes by touching designated sensor areas with the opposite hand, completing an electrical circuit. The ECG function enables AFib detection with rhythm analysis for sinus rhythm or AFib classification and exportable ECG reports to PDF for physician review. These features are available on current flagship models including Fenix 8 series, Epix Pro, and Venu 3.

According to PatentVest, Garmin’s patent portfolio covering smartwatches and biosignal monitoring technologies includes 10 patent families and 17 publications, with priority dates beginning in 2016 and the latest filings in 2025, spanning three jurisdictions. ECG-related patents specifically include 3 families and 5 publications, spanning 2016–2022 across one jurisdiction.

Garmin’s largest patent family, that includes a US family member granted in 2025 (US12336797B2) covers a wrist-worn fitness device (like a smartwatch) uses optical sensors to generate a PPG signal for measuring heart rate and blood oxygen (SpO₂).

US11350869B2, a patent covering Garmin’s ECG feature, covers a wrist-worn electronic device designed to perform and display an electrocardiogram (ECG). It uses two conductive contact points: A first electrode on the bezel or pushbutton, which the user touches with a finger from the opposite hand. A second electrode on the back plate, maintaining contact with the wrist. When both are touched, the device forms a closed electrical circuit through the user’s body, allowing it to record heart-generated bio-potentials and generate an ECG waveform. The waveform is processed and displayed on the watch in real time as a scrolling ECG image. Prior to being granted, the patent received multiple rejections from the examiner. One patent cited by the examiner to reject proposed claim 1, included a Motorola patent US20170181644A1, covering a wearable device with two electrodes to record an ECG signal.

Zepp Health

Zepp Health Corporation (NYSE: ZEPP), previously Huami, is a publicly traded Chinese health technology company headquartered in Hefei, Anhui, that produces Amazfit smartwatches with ECG functionality in select models. Amazfit watches with ECG are single-lead devices with two electrodes that contact the wrist and the finger and are intended to detect atrial fibrillation. Zepp Health introduced continuous PPG sensors in its Amazfit Bip and Stratos models in 2017, establishing a foundation for affordable heart rate monitoring using optical sensors for continuous tracking of heart rate, heart rate variability, and activity metrics. The company launched single-lead ECG spot-check capability in 2019 with the Amazfit Verge in China, later expanding ECG functionality to additional models globally after 2021. Users record an ECG via electrode arrays by touching designated sensor areas with the opposite hand, completing an electrical circuit. Zepp’s RealBeats algorithm provides continuous arrhythmia detection via PPG, while the ECG function enables on-demand AFib detection with heart health trend analysis and exportable reports through the Zepp OS platform. These features are available on current models including Amazfit Bip series and Amazfit Balance, though as of 2025, no models have FDA clearance for AFib detection in the US.

According to PatentVest, Zepp’s patent portfolio covering smartwatches and biosignal monitoring technologies includes 11 patent families and 13 publications, with priority dates beginning in 2011 and the latest filings in 2022, spanning four jurisdictions. ECG-related patents specifically include 3 families and 3 publications, filed between 2020 and 2021 across two jurisdictions

Zepp’s largest family (US9510788B2) covers a wrist-worn health analytics system that interprets real-time physiological data – especially heart rate variability (HRV) – to generate personalized feedback on stress, recovery, and overall well-being. US11191483B2 covers a smartwatch-based blood pressure monitoring system that coordinates measurements using multiple biosensors. The claims also include ECG as one of the cardiac input sensors (along with PPG), used to estimate heart rate and assess physiological readiness for measurement

CONCLUSION

The consumer cardiac wearable market has reached technological parity. All major manufacturers now deploy PPG for continuous rhythm surveillance and single-lead ECG for arrhythmia confirmation, resulting in overlapping capabilities and diminishing hardware differentiation. The competitive frontier has shifted toward algorithmic sophistication, regulatory validation, and integration with clinical data ecosystems. Despite massive global adoption, no consumer wearable can detect ischemia – the defining limitation separating wellness tracking from true medical diagnostics.

 

4.0 Ambulatory Cardiac Monitoring

Ambulatory electrocardiography (ECG) systems extend cardiac diagnostics beyond the hospital, allowing continuous or event-triggered recording of the heart’s electrical activity while patients go about daily life. These are prescription medical devices, cleared by regulators for specific diagnostic indications and reimbursed through established healthcare pathways. They bridge the gap between consumer wearables and in-hospital ECGs – combining the mobility of modern sensors with the signal fidelity and interpretive accuracy required for clinical decision-making. This field emerged to solve a persistent clinical challenge: most arrhythmic or ischemic events occur unpredictably outside medical supervision. Standard ECGs performed in hospitals capture only seconds of data, often missing transient abnormalities. Ambulatory systems extended monitoring windows from hours to weeks, enabling physicians to correlate symptoms such as palpitations, dizziness, or syncope with objective rhythm data.

Evolution of Ambulatory ECG Technology

The progression of ambulatory ECG devices reflects advances in miniaturization, battery life, data storage, and wireless communication. Over time, form-factor innovations have expanded monitoring duration and diagnostic scope while improving patient comfort.

Holter Monitors (1960s–2000s): The earliest ambulatory systems, introduced in the 1960s, used multiple adhesive electrodes connected to a portable recorder worn on the belt or shoulder strap. They captured continuous two- or three-lead ECG data for 24 to 72 hours, providing the first real-world view of rhythm abnormalities during daily activity. While reliable and clinically proven, Holter monitors were bulky, uncomfortable, and limited to short recording periods.

ECG Patches (2000s–Present): The next generation replaced wires and external recorders with compact adhesive sensors that adhered directly to the chest. Patches offered continuous one- to three-lead monitoring for up to two weeks, significantly improving wearability and patient compliance. They transmitted data wirelessly or stored it onboard for later analysis, allowing continuous rhythm surveillance with minimal user interaction.

Event Recorders (1990s–Present): Event recorders introduced patient activation into the workflow. Rather than recording continuously, these devices were pressed against the chest or worn as small accessories and activated when symptoms occurred. Event-based recording extended total monitoring time to several weeks, reducing data volume while capturing targeted symptom episodes.

Mobile and Handheld ECGs (2010s–Present): Recent systems allow patients to record short ECG segments on demand by touching integrated electrodes with their fingers or placing the device on the chest. These handheld or smartphone-connected devices capture single- to multi-lead recordings within seconds and can automatically analyze rhythms for abnormalities such as atrial fibrillation or bradycardia. They offer high diagnostic accessibility, though not continuous data collection.

Lead Configurations and Diagnostic Scope

The diagnostic capability of ambulatory ECG systems depends largely on lead count – the number of electrical perspectives captured from the body. Each additional lead provides a new spatial view of the heart’s electrical field, increasing accuracy for arrhythmia classification and ischemia detection.

• Single-Lead (1L): Measures one vector of cardiac activity. Adequate for detecting irregular rhythms such as atrial fibrillation but limited for localizing ischemia or conduction abnormalities.
• Three-Lead (3L): Captures electrical activity from right arm, left arm, and chest positions (Leads I, II, III). Provides improved rhythm discrimination and noise resistance while maintaining portability.
• Six-Lead (6L): Expands to six frontal-plane views (I, II, III, aVR, aVL, aVF), adding spatial context for rhythm analysis and limited ischemia detection.
• Twelve-Lead (12L): The diagnostic gold standard. Ten electrodes generate twelve perspectives, including six precordial (chest) leads for comprehensive spatial coverage. Provides the resolution needed for ischemia and infarction detection but remains impractical for extended outpatient monitoring.

 

Clinical Applications

Ambulatory ECG systems are prescribed for specific diagnostic indications:

• Arrhythmia detection and characterization: identifying atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or pauses
• Symptom correlation: linking dizziness, palpitations, or syncope to rhythm changes
• Therapy evaluation: assessing anti-arrhythmic medications or device function (pacemakers, ICDs)
• Ischemia monitoring (emerging): advanced systems aim to detect myocardial ischemia or evolving infarction outside the hospital

Despite technological advancement and market validation, current portable cardiac monitors face a fundamental limitation: devices using six or fewer leads cannot reliably diagnose myocardial ischemia or infarction. While single- to six-lead systems excel at rhythm analysis – detecting atrial fibrillation, bradycardia, and tachycardia – they lack the comprehensive spatial mapping required for ischemia detection. No ambulatory device with six or fewer leads is currently marketed with claims to predict or diagnose myocardial infarction, reflecting technical rather than regulatory constraints.

A solution combining true 12-lead diagnostic capability with the portability and extended monitoring duration of modern ambulatory systems would address this unmet clinical need, potentially enabling earlier ischemia detection and improved cardiac event triage outside hospital settings.

Competitive Landscape

The ability to monitor cardiac function and detect early warning signs outside clinical settings represents a substantial market opportunity, as demonstrated by the significant valuations achieved by companies in this space. Multiple companies have developed ambulatory cardiac monitoring solutions with proven commercial traction. iRhythm, which focuses on adhesive patch monitors, currently trades at a $3.62 billion market capitalization. AliveCor, known for handheld single-lead ECG devices, has raised over $154 million. Bardy Diagnostics was acquired for $375 million in 2021. These valuations reflect established demand across both direct-to-consumer self-pay markets and prescription-based ambulatory monitoring with healthcare reimbursement.

 

Analytical Framework

For each company, PatentVest conducted a standardized evaluation across six dimensions relevant to ambulatory ECG performance and IP defensibility:

• Core Technology: The fundamental sensing and signal acquisition method underlying each system.
• Product Offering: The specific medical devices and monitoring solutions within each company’s portfolio.
• Form Factor: The physical design and patient interface of the device – adhesive patch, belt, cable-free handheld, or wearable configuration – affecting comfort, adherence, and data quality over extended monitoring periods.
• Diagnostic Capability: The scope of diagnostic information provided, from arrhythmia detection and symptom correlation to emerging ischemia and infarction analysis enabled by advanced lead systems or reconstruction algorithms.
• Regulatory Status: The regulatory classification and clearance pathway (e.g., FDA 510(k), Class II), as well as supporting clinical evidence validating the device’s diagnostic claims and intended use.
• Intellectual Property Portfolio: The scale and composition of each company’s patent holdings related to ambulatory ECG 

This framework enables an apples-to-apples comparison of how each company’s technology foundation, diagnostic scope, clinical validation, and IP strength define its competitive position within the ambulatory ECG market.

Ambulatory ECG Companies 

Patent Portfolio Overview – Ambulatory Monitoring Companies

 

iRhythm Technologies

iRhythm Technologies (NASDAQ: IRTC), a publicly traded digital healthcare company headquartered in San Francisco, produces continuous ECG monitoring patches for arrhythmia detection. The Zio XT and Zio AT are single-lead ECG patches with adhesive electrodes that contact the chest and are intended to detect atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and pauses. iRhythm received initial FDA 510(k) clearance in 2011 for its Zio XT patch, which enables continuous 14-day ECG monitoring with store-and-forward data analysis. The Zio AT, launched later, added real-time alerts and daily reports via gateway device transmission. In 2022, iRhythm launched Zio Watch in collaboration with Verily, using continuous photoplethysmography (PPG) for AFib detection. Users wear the Zio XT patch continuously for up to 14 days with data uploaded after monitoring concludes, while Zio AT transmits data in real-time for immediate clinician review. The patches are prescribed when physicians suspect arrhythmia but require extended monitoring beyond standard office ECGs. These features are available on current models Zio XT, Zio AT, and Zio Watch.

iRhythm’s patent portfolio includes 211 publications across 10 families filed between 2011 and 2025 in ten jurisdictions. The portfolio protects long-term adhesive patch architecture, cloud analytics infrastructure, and AI-driven diagnostic systems. iRhythm’s foundational patents cover skin-adherent patches with onboard memory, power management, and data relay systems enabling continuous single-lead recording for up to two weeks. Seven active patent families (2011-2024) form the core hardware IP covering long-term adhesion through flexible geometries and breathable adhesives, electrical and mechanical integration for disposable patches, pre-skin preparation tools, and optical sensor extensions supporting the Zio Watch platform. Two core families anchor AI capabilities including machine-learning algorithms for automated arrhythmia classification and deep-learning architectures combining ECG with physiological parameters to infer sleep apnea. Two software patents protect wireless connectivity, edge encryption, data compression, and cloud integration enabling the ZEUS analytics platform.

AliveCor

AliveCor, a private medical device and AI company headquartered in Mountain View, California, produces portable ECG devices for mobile cardiac monitoring. AliveCor offers single-lead, six-lead, and twelve-lead ECG devices with two or more electrodes that contact the fingers, chest, or limbs and are intended to detect atrial fibrillation, bradycardia, tachycardia, and QTc prolongation. AliveCor was the first to receive FDA clearance for a medical device accessory to the Apple Watch. The company launched KardiaMobile in 2012 as the first FDA-cleared smartphone-connected ECG, enabling single-lead recording via finger electrodes. KardiaMobile 6L followed in 2017, capturing six frontal-plane leads (I, II, III, aVR, aVL, aVF) through two top electrodes and one bottom electrode. KardiaMobile Card launched in 2019 as a credit-card-thin device for wallet portability. Kardia 12L, a professional-grade cable-based system, provides full 12-lead ECG with standard disposable electrodes. Users record 30-second ECGs by touching device electrodes with fingers or placing the device on the chest, with results analyzed through the Kardia app. Without a KardiaCare membership ($9/month or $99/year), devices detect four arrhythmia types; with membership, seven types plus professional ECG review. These features are available across KardiaMobile, KardiaMobile 6L, KardiaMobile Card, and Kardia 12L.

AliveCor’s patent portfolio includes 251 documents across 62 families filed between 2011 and 2025 in eight jurisdictions. The portfolio covers multiple form factors including credit card/handheld devices, watch/wrist devices, 6-lead and 12-lead variants, stethoscope integration, blood-pressure monitor integration, multi-parameter wearables, ultraviolet cardiac sensing, bed/commode sensors, template/electrode-placement systems, and cylindrical/pen-type devices. AI and machine learning IP covers lead synthesis enabling 12-lead reconstruction from two or three measured inputs, signal classification and QT analysis using deep learning, biometric identification via ECG waveforms, text-signal embedding models, and health prediction/risk scoring combining ECG with vital signs. Software patents protect secure storage, visualization, and transmission forming the backbone of AliveCor’s connected ecosystem, including mobile-to-cloud ECG management, live streaming workflows, arrhythmia scoring, QT interval measurement, and anomaly detection algorithms powering the KardiaCare subscription platform.

HeartBeam

HeartBeam Inc. (NASDAQ: BEAT), a publicly traded medical technology company headquartered in Santa Clara, California, is developing portable electrophysiology (ECG) systems capable of producing full synthesized 12-L ECGs. The AIMIGo is a credit-card-sized, cable-free device with five electrodes that contact the chest and hands and is cleared for arrhythmia assessment, including atrial fibrillation. HeartBeam is actively expanding their portfolio to include extended indications, including to detect acute coronary syndrome and myocardial ischemia. HeartBeam received FDA 510(k) clearance in 2024 for its three-lead ECG recording, with a pending clearance for full 12-lead synthesis. The company’s core technology captures three dimensional electrical vectors, captured from three, distinct directions through a proprietary resistive network that triangulates the Z-axis between arm and chest electrodes, enabling reconstruction of clinical-grade ECGs. Future products include an adhesive patch for continuous monitoring, a wrist-worn watch, and a cloud-based AI platform trained on over one million ECGs. In the future, users record ECGs by placing the credit-card device on the chest while touching finger electrodes, with results analyzed for ischemia and arrhythmia detection. HeartBeam addresses the diagnostic blind spot of existing remote monitors by enabling detection of ST-segment changes, T-wave inversions, and Q-wave formations that signal myocardial infarction or unstable angina – capabilities that single-lead systems lack.

HeartBeam’s patent portfolio includes 82 publications across 15 families filed between 2016 and 2025 in eight jurisdictions. The foundational patent (US10117592B2) covers a resistive network that captures the Z-axis through triangulation between arm and chest electrodes, the core invention behind AIMIGo’s cable-free ECG platform. Form-factor coverage includes credit card/handheld devices, patch devices transforming from single-lead to three-lead mode when fingers contact additional electrodes, watch devices with all ECG electrodes capable of capturing the 3-D, signals and will be removable from the wrist for chest placement, continuous ambulatory patches for adhesive chest placement, and electrode placement systems for accurate lead synthesis. AI and signal-synthesis IP covers 12-lead reconstruction algorithms mathematically inferring missing leads from three measured ECG axes, automated diagnostics enabling on-device or cloud-based interpretation for arrhythmia and ischemia, and signal processing including digital filtering, vector projection, and transformation functions enabling clean lead synthesis.

Bardy Diagnostics (Baxter/Hillrom)

Bardy Diagnostics, acquired by Baxter (via Hillrom) for $367 million in August 2021, developed continuous-wear, wire-free ambulatory patch monitors optimized for P-wave signal capture. The Carnation Ambulatory Monitor (CAM) is a single-lead adhesive patch with two electrodes that contact the sternum and is intended to detect atrial arrhythmias with enhanced P-wave clarity. Bardy launched the CAM patch in the mid-2010s with a focus on sternal placement to create an aVF-like lead optimized for P-wave amplitude, addressing signal-to-noise limitations inherent in short patch vectors. Users wear the patch for up to 14 days with data transmitted to cloud-based software for analysis. The system provides three report views: near-field (8-second traditional view with R-R measurements), medium-field (56-second snapshot displaying 24 seconds before and after an episode), and far-field (40-minute R-R interval plot capturing 20 minutes before and after an episode). Advanced circuit design and compression algorithms process signals to maintain diagnostic fidelity despite single-lead constraints. The CAM patch links to a web-based portal where physicians and patients access ECG analysis services and reports. Bardy’s patent portfolio includes 384 publications across 92 families filed over 11 years in five jurisdictions. The IP centers on sternal electrode placement optimizing P-wave signal visibility, circuit designs minimizing noise in single-lead configurations, compression algorithms maintaining diagnostic fidelity, and cloud-based interpretation workflows. Bardy’s strategy was vertical integration: owning the patch design, data pipeline, and IDTF service layer to create a complete ambulatory ECG business rather than just a device.

 

Preventice Solutions (Boston Scientific)

Preventice Solutions, acquired by Boston Scientific for $1.2 billion in 2021, operates a remote cardiac monitoring platform combining adhesive patch sensors with cellular telemetry. The BodyGuardian MCT is a wearable patch or belt transmitter with one to three electrodes that contact the chest and is intended to detect arrhythmias and rhythm abnormalities. Preventice developed its remote monitoring platform in the 2010s, integrating patch sensors with real-time data transmission and physician workflow systems. Users wear the patch or belt transmitter continuously with data transmitted via cellular networks for immediate clinician review. The platform operates under established CPT reimbursement codes for mobile cardiac telemetry, providing continuous rhythm diagnostics and event detection. Boston Scientific acquired Preventice to extend its cardiac-diagnostics footprint into cloud-connected monitoring and long-term patient engagement, operating as the company’s primary connected-diagnostics arm. The acquisition secured Boston Scientific a scalable platform for cardiac data collection and remote monitoring services reimbursed through standard healthcare pathways. According to PatentVest, Preventice’s portfolio includes 33 publications across 14 families filed over 12 years in four jurisdictions. The patents protect wireless ECG monitoring infrastructure, patch and gateway device architectures, and cloud telemetry systems enabling real-time rhythm diagnostics and event detection integrated into physician workflows.

 

BioTelemetry (Philips)

BioTelemetry, acquired by Philips for $2.8 billion in 2020, operates one of the largest cardiac diagnostics service platforms globally. The ePatch and CardioNet MCT are wireless ECG monitors with one to three electrodes that contact the chest and are intended to detect arrhythmias and cardiac events. BioTelemetry built its platform in the 2000s, combining adhesive patch monitors with clinician-staffed interpretation centers to provide 24/7 monitoring services. Users wear the patch continuously with data transmitted to gateway devices for real-time analysis and clinician review. The platform includes comprehensive arrhythmia detection, event classification, and reporting services reimbursed under established mobile cardiac telemetry codes. Philips acquired BioTelemetry to anchor its “hospital-to-home” strategy, integrating continuous cardiac monitoring with its existing hospital monitoring business. Now operating as part of Philips Connected Care, BioTelemetry provides the service-layer infrastructure including IDTF operations, reimbursement pathways, and clinical workflow integration that complement Philips’ acute care monitoring portfolio. According to PatentVest, BioTelemetry’s portfolio includes 53 publications across 3 families filed over 8 years in ten jurisdictions. The patents protect wireless patch architectures, gateway device communication systems, and cloud-based interpretation platforms enabling continuous cardiac monitoring with clinician-staffed analysis centers.

 

Conclusion

Ambulatory ECG systems extend monitoring duration and clinical accuracy far beyond consumer wearables but remain constrained by limited lead counts and incomplete spatial coverage. The category has matured into a multi-billion-dollar segment defined by prescription-based reimbursement and strong service integration, yet diagnostic scope remains confined to basic arrhythmia detection. HeartBeam’s 3D ECG technology represents the only credible attempt to bridge this diagnostic ceiling, combining cable-free mobility with clinical-grade potential for ischemia detection in a portable format.

 

5.0 Traditional Hospital 12L ECG

Traditional 12-lead electrocardiography (ECG) remains the cornerstone of cardiac diagnostics, providing a comprehensive electrical map of the heart used to detect arrhythmias, ischemia, infarction, and conduction abnormalities. The system records signals from ten electrodes placed on the limbs and chest to generate twelve electrical perspectives, offering spatial and temporal resolution unmatched by limited-lead configurations. It is the definitive clinical tool for diagnosing acute coronary syndromes, quantifying myocardial injury, and guiding therapeutic intervention in real time.

Developed over a century ago and refined through successive generations of instrumentation, the 12-lead ECG established the diagnostic framework that underpins all modern cardiac monitoring technologies. Its precision and reproducibility made it indispensable in emergency medicine, cardiology, and perioperative care, forming the reference standard for both device validation and regulatory benchmarking. While waveform interpretation has evolved through computerized algorithms and digital signal processing, the fundamental principle – multi-vector surface recording of the heart’s electrical activity – has remained unchanged.

Over the past two decades, traditional ECG systems have transitioned from analog to fully digital architectures, integrating automated interpretation, network connectivity, and cloud-based data storage. Clinical-grade 12-lead systems now enable rapid acquisition, automated rhythm classification, and remote cardiologist review, streamlining workflow in emergency and inpatient settings. Despite these advancements, the technology remains largely confined to supervised environments requiring trained personnel, electrode placement precision, and controlled conditions to ensure signal integrity.

The market is dominated by institutional manufacturers – Philips, GE Healthcare, Schiller AG, and Nihon Kohden – whose systems have defined hospital-based cardiac diagnosis for decades. Their business model centers on capital equipment sales, hospital procurement cycles (typically 8-10 year replacement cycles), and proprietary enterprise networks integrating ECG acquisition with centralized data management. These companies operate within a procedural economy optimized for hardware scale and regulatory durability rather than digital transformation. Even as vendors introduce AI modules and cloud connectivity, their commercial motion mirrors industrial equipment sales rather than software-driven health platforms.

The primary limitation of traditional 12-lead ECG lies not in diagnostic performance but in accessibility and temporal coverage. While it remains the gold standard for ischemia and infarction detection, its reliance on in-hospital infrastructure restricts availability to the moment symptoms occur – capturing only seconds or minutes of cardiac activity during scheduled appointments. In contrast, consumer wearables and ambulatory patches now capture thousands of hours of rhythm data per patient annually. This shift in data volume and context has fundamentally altered the economics of cardiac monitoring, with leadership migrating toward platforms that enable continuous, predictive intelligence rather than episodic testing.

Together, these systems define the foundation and evolution of cardiac diagnostics: traditional 12-lead ECG as the clinical benchmark and regulatory standard, ambulatory systems extending monitoring beyond hospital walls, and emerging portable 12-lead solutions seeking to replicate clinical-grade diagnostic fidelity in outpatient or home settings.

 

Cardiac Patent Portfolios – Traditional Device Incumbents

Company Profiles

 

Koninklijke Philips N.V.

Koninklijke Philips N.V. is a global health technology company specializing in diagnostic imaging, patient monitoring, and connected care solutions for hospitals and healthcare systems worldwide. Headquartered in Amsterdam, Netherlands, with major operations in Cambridge, Massachusetts, Philips operates across more than 100 countries. Philips produces a comprehensive suite of 12-lead ECG solutions for clinical diagnostics and cardiac monitoring across hospital, emergency, and home care settings.  The IntelliVue patient monitoring platform – widely deployed in critical care and emergency departments 0 captures diagnostic 12-lead ECGs with 10 standard electrodes. Their Cardiac Workstation series (5000, 7000) provides advanced desktop and portable ECG platforms for full hospital diagnostic workflows, capturing, interpreting, and archiving 12-lead ECGs. Philips telemetry platforms) provide enterprise-wide continuous cardiac monitoring for inpatient and post-discharge care, streamlining alarm management and integrating with central monitoring units. In 2025, Philips launched the ECG AI Marketplace – a central platform providing plug-and-play access to FDA-cleared AI algorithms from multiple vendors integrated within Philips hospital ECG infrastructure, enhancing diagnostic workflow and enabling faster review and clinical decision support at the point of care. Philips also offers remote, clinical-grade 12-lead ECG patch systems for decentralized clinical trials and patient monitoring at home, leveraging cloud-based data transmission and secure access for hospitals and research teams. Philips’ acquisitions of BioTelemetry ($2.8 billion, 2020) and Cardiologs AI (2021) extended reach into ambulatory monitoring and AI-driven interpretation, though core business remains anchored to institutional infrastructure rather than consumer-facing portable diagnostic systems. According to PatentVest, Philips holds 3,309 cardiac publications across 879 families dating back to 1972, the largest and most diversified portfolio among traditional incumbents.

 

GE HealthCare Technologies Inc

GE HealthCare Technologies Inc. is a leading global health technology company, specializing in medical imaging, ultrasound, patient care solutions, and pharmaceutical diagnostics for hospitals and health networks worldwide. Headquartered in Chicago, GE HealthCare operates in over 100 countries and was officially spun out from General Electric in January 2023 to form a standalone, publicly traded company. GE HealthCare produces a comprehensive suite of 12-lead ECG solutions for clinical diagnostics and cardiac monitoring. The MAC Series – GE Healthcare’s portfolio of advanced ECG systems including flagship models MAC 1200, MAC 2000, and MAC VU360 – captures simultaneous 12-lead ECG signals using 10 standard electrodes for comprehensive cardiac assessment in hospital and clinical settings. These devices are intended to detect arrhythmias, ischemia, and conduction abnormalities with high-fidelity acquisition, pacemaker detection, and smart workflow tools that integrate seamlessly into hospital networks and clinical information systems. The Marquette 12SL program is GE Healthcare’s proprietary automated ECG measurement and interpretation algorithm, embedded in MAC Series devices and used globally. It provides automated rhythm, interval, axis, and morphology analysis supporting guideline-driven detection of arrhythmias and acute myocardial infarction—often considered the industry gold standard for automated ECG interpretation. GE’s 12RL technology reconstructs a full 12-lead ECG from only six electrodes by mathematically deriving four precordial leads, enabling continuous monitoring when full 10-electrode placement is impractical. GE Healthcare’s cardiac IP includes 1,041 publications across 479 families dating back to 1968, dominated by 12-lead acquisition, signal processing, and telemetry systems.

 

Schiller AG

Schiller AG is a Swiss medical technology company headquartered in Baar, Switzerland, specializing in cardiopulmonary diagnostics, defibrillation, and patient monitoring systems. Founded in 1974, Schiller produces a comprehensive portfolio of 12-lead ECG solutions for resting diagnostics, exercise stress testing, ambulatory care, and pediatric applications across hospital, clinic, urgent care, and mobile medicine settings worldwide. The CARDIOVIT series represents Schiller’s flagship 12-lead ECG platform, with the CARDIOVIT AT-102 G2 serving as the latest-generation resting ECG device for hospitals and clinical practices, capturing simultaneous 12-lead ECG signals using 10 standard electrodes for comprehensive cardiac assessment. The CARDIOVIT FT-1 provides portable PC-powered 12-lead ECG capability for rapid diagnostics and mobile applications, enabling field deployment in ambulances, urgent care centers, and remote clinical environments. According to PatentVest, Schiller maintains 41 publications across 15 families filed since 1998, centered on ECG hardware design and embedded signal processing.

 

Nihon Kohden Corporation

Nihon Kohden Corporation is a Japanese medical technology company specializing in patient monitors, electrocardiographs, defibrillators, and neurology solutions. Founded in 1951 and headquartered in Tokyo, Nihon Kohden is publicly traded on the Tokyo Stock Exchange and operates in over 120 countries.  Nihon Kohden provides a diverse portfolio of 12-lead ECG devices for hospital, emergency room, clinic, and ambulatory care settings, with systems known for high-fidelity signal acquisition, rapid analysis, and seamless network integration. The Cardiofax S (1250A) is a compact 12-lead electrocardiograph with large color screen and user-friendly keyboard, providing simultaneous display and recording of all 12 leads.The Cardiofax M is an interpretive 12-lead ECG recorder. The Life Scope G5 and BSM-6000 series bedside monitors provide advanced patient monitoring with integrated diagnostic 12-lead ECG capability, simultaneous ECG acquisition, full arrhythmia detection, QTc/AF detection, ST-segment analysis, and drug/dynamic calculations.  Clinical applications span hospital and emergency room diagnostic ECGs, bedside and continuous multi-parameter monitoring, and clinic and ambulatory diagnostics including pediatrics and high-acuity cardiac triage. According to PatentVest, Nihon Kohden holds 519 cardiac publications across 206 families dating back to 1971.

 

Conclusion

Traditional 12-lead systems continue to anchor institutional cardiology and remain the diagnostic gold standard for ischemia and infarction. However, decades of hospital-centric business models, slow procurement cycles, and reliance on stationary infrastructure have constrained innovation. While incumbents like Philips and GE Healthcare pursue incremental AI upgrades and digital connectivity, none have re-engineered their platforms for mobility. The next wave of disruption will not come from further institutional refinement, but from technologies that replicate 12-lead diagnostic fidelity beyond hospital walls.

 

6.0 12L ECG IP Landscape

The 12-lead electrocardiogram – the clinical gold standard for cardiac diagnosis for over a century – is undergoing its first major technological transition in decades. To quantify where innovation is occurring, PatentVest built a focused global patent landscape capturing active developments in 12-lead and 12-lead-equivalent ECG systems.

Using a two-layer keyword strategy combining “ECG,” “electrocardiogram,” or “electrocardiograph” with “12-lead,” “twelve-lead,” or related variants, the analysis searched global patent databases for filings with priority dates between 2015 and 2025, isolating current competitive activity. The refined dataset included 1,024 publications across 581 families from 243 assignees, spanning 24 jurisdictions, with a five-year CAGR of 23.9% – evidence of accelerating innovation in a traditionally mature field that had remained largely static for decades.

 

Top Companies In The 12L ECG IP Landscape (2015-2025)

The distribution reveals a fundamental shift: traditional hospital incumbents (GE, Philips) are being outpaced by portable-system challengers (HeartBeam, AliveCor) and AI-algorithmic innovators (Mayo Clinic, Tempus, Anumana) in recent filing activity.

 

Incumbents: Refining the Hospital Standard

Traditional 12-lead incumbents such as GE Healthcare and Philips continue to define the institutional benchmark for diagnostic precision but no longer lead innovation in form factor or accessibility. GE Healthcare (26 patent publications, 9 families) focuses on neural-network and rule-based interpretation of standard 12-lead ECGs, strengthening automated diagnosis inside existing hospital workflows rather than attempting cable-free acquisition or portable deployment. Philips (13 patent publications, 2 families) protects vessel-specific transforms for ischemia detection and enterprise reliability through cable-interchange systems and lead-system validation protocols. Both companies continue refining diagnostic algorithms and workflow integration for their installed base but show minimal patent activity around portable 12-lead systems, cable-free architectures, or consumer-facing deployment strategies.

 

Challengers: Portable 12-Lead Systems

A new generation of companies is translating 12-lead diagnostic fidelity into mobile form factors, attempting to bring clinical-grade ischemia detection outside clinical walls. HeartBeam (25 patent publications, 5 families) uses 3-D technology to capture three electrical axes through resistive networks and mathematically reconstruct full 12-lead equivalents from cable-free form factors. The approach has the potential to directly address ischemia detection at the point of symptoms – at home, in the workplace, or during activity – with FDA clearance achieved in 2024 for their three-lead ECG platform for arrhythmia assessment, and pending clearance for full 12-lead synthesis for arrhythmia assessment currently underway. AliveCor (17 patent publications, 5 families) claims 12-lead electrocardiograms generated from three-electrode or reduced-form-factor devices using AI-driven lead synthesis algorithms. However, the company’s actual Kardia 12L product requires traditional cables and professional physician supervision for proper electrode placement—eliminating the portability and patient autonomy that define successful ambulatory monitoring. QT Medical (13 patent publications, 10 families) advances small-footprint systems preserving full 12-lead geometry with simplified setup for clinics and homes while retaining standard electrode placements.

 

AI-Algorithmic Players: Computing 12-Lead Intelligence

Parallel to hardware challengers, a distinct cohort of AI-driven companies is transforming the 12-lead ECG from a fixed measurement protocol into a computational biomarker that can be inferred, reconstructed, or predicted from limited inputs. Mayo Clinic (14 patent publications, 6 families) protects atrial fibrillation screening, ejection-fraction detection, troponin-level inference, and lead-invariant processing across different lead configurations—validating that diagnostic information traditionally requiring 12 leads can be extracted computationally from fewer inputs. Tempus AI (6 patent publications, 1 family) trains machine-learning models on clinical 12-lead data, then retunes them for devices with fewer leads, potentially bridging the diagnostic gap through software rather than hardware innovation. Eko Health (5 patent publications, 1 family) combines ECG and heart sounds with neural networks to infer low ejection fraction, arrhythmias, and valve disease from portable sensors. Additional players including Anumana (1 patent publication, 1 family), Medical AI Co. (17 patent publications, 7 families), and Bodyfriend Co. (6 patent publications, 3 families) reflect substantial Asian investment in deep-learning ECG interpretation and signal processing. Collectively, these companies are redefining what a 12-lead ECG represents: not a fixed configuration of ten electrodes, but a learned model of the heart’s electrical behavior derived from hospital datasets and computationally reconstructed from reduced inputs.

 

7.0 Conclusion

 

Strategic Outlook for Cardiac Diagnostics

Cardiac diagnostics are entering a decade of structural convergence, where consumer wearables, advanced ambulatory monitors, and institutional 12-lead systems begin to overlap in capability and ambition. Despite rapid market growth and major technological advances, a persistent diagnostic gap remains – the inability to deliver clinical-grade ischemia detection and continuous monitoring in a truly portable form factor.

Consumer wearables – now shipped in the hundreds of millions – offer unprecedented accessibility and continuous rhythm monitoring via PPG and single-lead ECG, but cannot detect myocardial ischemia or infarction due to geometric and technological constraints. Ambulatory monitors extend diagnostic reach by capturing days-to-weeks of ECG data in cable-free and patch-based designs, yet current configurations cannot reliably diagnose acute coronary syndromes. Institutional 12-lead systems, though the clinical gold standard, anchor diagnosis to hospital infrastructure and brief, episodic encounters – often after irreversible myocardial damage has occurred.

Intellectual property strategies, regulatory milestones, and AI-driven analytics further fuel competition across all tiers, but none have yet unified mobility, fidelity, and comprehensive coverage. The only promising pathway is 3D ECG reconstruction, epitomized by HeartBeam’s FDA-cleared system – able to generate 12-lead-equivalent insights from a portable device outside hospital settings. However, broader adoption, clinical validation, and commercial scaling of the 3D ECG platforms remain at the frontier of technical and clinical translation.

The strategic imperative is clear: next-generation cardiac intelligence will be defined by platforms that bridge prevention, detection, and timely intervention – delivering clinical-grade insight wherever and whenever symptoms begin. Companies that unify extended monitoring, 12-lead-equivalent diagnostic fidelity, and real-time interpretation will redefine cardiac diagnostics – and determine how and where the next generation of cardiovascular care begins.

This article is provided for informational purposes only and should not be construed as an offer, solicitation, or recommendation to buy or sell any security, nor as personalized investment, legal, tax, or accounting advice. It is not a “research report” and should not be relied upon as such. The views expressed are based on PatentVest’s independent analysis of intellectual property data and public information as of the publication date and may change without notice. HeartBeam, Inc. is an IP Strategy and Legal client of PatentVest, and PatentVest has been compensated by HeartBeam for services. PatentVest, its principals, and/or its affiliates may have financial interests in HeartBeam or other companies mentioned. Our affiliated company, MDB Capital, has provided investment banking services to, and holds an equity interest in, HeartBeam within the past twelve months. These relationships may present potential conflicts of interest. Readers should conduct their own due diligence and consult their professional advisors before making any investment decisions.