Smart Wearable ECG Monitors Market Size, Share & Trends Analysis Report By Type (Patches, Chest Straps), By Distribution Channel (Pharmacies, Online Channel), By End Use (Hospitals, Clinics), By Region, And Segment Forecasts, 2025 - 2030

Smart Wearable ECG Monitors Market Summary

For instance, in August 2024, under the U.S. Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H) launched a new funding initiative through the PRECISE-AI program. This program aims to enhance AI tools in clinical care by detecting misalignments with their training data and auto-correcting them to ensure optimal performance. The market is further propelled by increasing consumer awareness regarding preventive healthcare and the convenience offered by wearable ECG devices for continuous cardiac monitoring. These devices are gaining popularity among patients with known heart conditions, health-conscious individuals, and fitness enthusiasts. The growing adoption of telehealth and remote patient monitoring solutions has significantly accelerated the use of smart ECG wearables. Moreover, major technology players are increasingly integrating AI-powered analytics into wearable devices to enhance diagnostic accuracy and enable early intervention. For instance, researchers at the Mayo Clinic developed an AI algorithm capable of analyzing single-lead ECG tracings from the Apple Watch to detect low ejection fraction, a potential indicator of a weak heart pump. This study demonstrated how data from consumer-grade wearables can be harnessed for clinical insights, underscoring the role of AI in advancing remote cardiac care.

Furthermore, the expansion of smart wearable ECG monitors capabilities is being driven by strategic investments and partnerships aimed at enhancing device accuracy and usability. Companies are increasingly incorporating multi-sensor platforms and AI-driven diagnostics to offer a more comprehensive cardiovascular health profile. For instance, in August 2023, Withings received FDA clearance for its Body Scan smart scale, a "connected health station" equipped with a six-lead ECG, segmental body composition analysis, and nerve activity assessment. This device collects ECG readouts via electrodes located on the retractable handle and the base of the scale, allowing it to detect atrial fibrillation and provide users with a holistic health check during their daily weigh-in. Such innovations reflect a growing trend toward multifunctional health devices that bridge the gap between consumer wellness tools and clinically actionable data, expanding the role of wearable ECG monitors in proactive and preventive care strategies.

The COVID-19 pandemic positively impacted the smart wearable ECG monitors market by accelerating the adoption of remote health monitoring technologies. As healthcare systems faced overwhelming patient loads and limited in-person consultations, both patients and providers increasingly turned to wearable devices for real-time cardiac monitoring and management of chronic conditions outside traditional clinical settings. This shift highlighted the value of continuous, home-based health tracking, particularly for at-risk cardiovascular patients, and led to increased investment and innovation in wearable ECG technologies. Moreover, the pandemic underscored the importance of integrating such devices with telehealth platforms, laying the foundation for long-term growth and adoption in the post-pandemic digital health landscape.

AI in Smart wearable ECG Monitors Market.

Artificial Intelligence (AI) is playing an increasingly pivotal role in the evolution of the smart wearable ECG monitors market. By enabling real-time analysis of ECG signals, AI algorithms can detect irregular heart rhythms such as atrial fibrillation, bradycardia, or tachycardia, with higher accuracy and faster response times than traditional methods. Advanced machine learning models are being integrated into wearable ECG devices to interpret vast amounts of physiological data, identify early signs of cardiac abnormalities, and reduce false positives that typically burden clinical workflows. In addition, AI-powered platforms facilitate personalized health insights by learning user-specific patterns and predicting potential cardiac events. This intelligence is particularly valuable for continuous monitoring in outpatient or home settings, enabling early intervention and reducing the need for emergency care. The integration of AI also supports seamless data sharing with electronic health records (EHRs), enhancing care coordination and contributing to broader digital health ecosystems.For instance, in June 2024, AliveCor received dual FDA clearance for its Kardia 12L ECG system, which utilizes the KAI 12L AI technology to identify 35 distinct cardiac conditions comprising 14 types of arrhythmias and 21 morphological patterns underscoring the growing role of AI in enhancing diagnostic precision within wearable ECG solutions.

Market Concentration & Characteristics

The chart below illustrates the relationship between market concentration, industry characteristics, and industry participants. The x-axis represents the level of industry concentration, ranging from low to high. The y-axis represents various industry characteristics, including industry competition, impact of regulations, level of partnerships & collaborations activities, degree of innovation, and regional expansion. For instance, the smart wearable ECG market is moderately concentrated, with a mix of established medical device manufacturers and emerging technology startups competing actively. The degree of innovation, level of partnerships & collaboration, and regulatory impact are high, while regional expansion is experiencing rapid growth, particularly in Asia-Pacific and North America.

The degree of innovation in the industry is moderate to high driven by advances in sensor technology, AI-based diagnostics, and seamless integration with telehealth and electronic health records (EHR). The market is witnessing the development of multi-lead ECG wearables, improved battery life, and real-time data analytics for early detection of cardiac abnormalities. For instance, in September 2020, Fitbit launched its wearable device featuring FDA-cleared ECG capabilities combined with enhanced AI algorithms to detect atrial fibrillation and other arrhythmias, highlighting the push toward more accurate and user-friendly cardiac monitoring solutions.

The level of partnerships & collaboration activities by key players in the industry is high aimed at accelerating innovation and expanding market reach. For instance, in June 2024, Anumana, AI-driven health technology company, partnered with InfoBionic.Ai, a digital health company. This collaboration aimed to develop and commercialize advanced remote cardiac care solutions by combining Anumana’s ECG-AI technology with InfoBionic.Ai’s MoMe ARC platform, enabling earlier detection of cardiac diseases in remote patient monitoring settings.

The impact of regulations on the market is high regarding device safety, data privacy, and interoperability standards. Regulatory agencies such as the FDA and the European Medicines Agency (EMA) have streamlined approval pathways for digital health products, fostering faster time-to-market for innovative wearable ECG solutions. Compliance with these regulations is crucial for market players to maintain trust and enable clinical use.

The industry's level of regional expansion is moderate. Regional expansion has become a key growth strategy for medical devices companies in the smart wearable ECG monitors market, significantly broadening patient access, driving revenue, and diversifying product portfolios.

Case Study:

B-Secur, in collaboration with Fourth Frontier, carried out a clinical evaluation to test the effectiveness of their single-lead ECG chest strap device, the FX+, which uses B-Secur’s HeartKey Core software. The purpose of the study was to determine how well the device could identify various heart rhythms such as normal sinus rhythm, atrial fibrillation, slow heart rate, and fast heart rate. The results from the device’s automated analysis were compared against expert reviews of standard 12-lead ECGs and readings from the KardiaMobile device to verify accuracy.

 Study Design:

• 82 adult patients participated in the study at an outpatient cardiology clinic.

• Two consecutive sets of 30-second ECG recordings were obtained:

  • First set: FX+ and standard 12-lead ECG simultaneously.

  • Second set: FX+ and KardiaMobile device simultaneously.

• The automated rhythm outputs from the FX+ were compared to the manual interpretations by cardiologists.

Key Findings:

• The FX+ with HeartKey Core software demonstrated high accuracy:

  • 96.8% sensitivity

  • 94.3% specificity

• A cardiologist determined that all FX+ ECG readings were equivalent to lead I of the concurrently recorded 12-lead ECG.

• The FX+ device reported fewer inconclusive readings (11.9%)-where the ECG signal quality was insufficient for arrhythmia classification-compared to the KardiaMobile device (13.6%).

Conclusions:

The study concluded that the FX+ chest strap, when integrated with B-Secur’s HeartKey Core software, provides accurate and reliable arrhythmia detection comparable to traditional 12-lead ECG systems. This validates the potential of single-lead ECG chest strap devices as effective tools for long-term cardiac monitoring and arrhythmia detection.

Type Insights

Based on type, the patches segment dominated the market with a revenue share of 68.60% in 2024. Moreover, this segment is expected to register the fastest CAGR during the forecast period. The segment's large share is attributed to its unique combination of comfort, clinical reliability, and advanced functionality. These adhesive, lightweight devices are designed for continuous, long-term wear, enabling round-the-clock cardiac monitoring without causing discomfort or disrupting daily activities.

Furthermore, the growing focus of key players on innovation of smart ECG patches is contributing to the segments’ growth. For instance, In February 2024, X-Trodes received FDA 510(k) clearance for its X-Trodes System M, Smart Skin solution, a wireless wearable technology for evolved electrophysiological monitoring. This system features customizable multi-modal dry-printed electrode patches capable of monitoring various biopotential signals across the body, including EEG, EOG, EKG/ECG, and EMG data.

Distribution Channel Insights

Based on the distribution channel, pharmacies dominated the market with the largest revenue share of 39.42% in 2024. Pharmacies have become crucial distribution channels for smart medical devices owing to their enhanced accessibility. As patients increasingly seek convenient solutions for managing chronic conditions at home, pharmacies are well-positioned to fulfill this demand. By integrating smart medical devices into their offerings, pharmacies improve patient engagement and enhance medication adherence & monitoring.

Online channel is expected to grow at the fastest CAGR during the forecast period. Online platforms have made it possible for manufacturers to reach a wider audience and for customers to purchase devices online. In addition, online marketplaces, such as Medtronic's online store, allow customers to browse and purchase devices directly from the manufacturer. This shift towards online distribution has increased accessibility and convenience for customers while reducing costs and improving supply chain efficiency.

End use Insights

The hospitals segment held large revenue share of 44.16% in 2024. This growth is primarily attributed to the significant patient population served by hospitals, particularly in emerging and low-income nations, which is driving the demand for mobile ECG devices.

The homecare segment is poised to register the fastest CAGR in the market during the forecast period. This growth is attributed to its cost-effectiveness and convenience for medical treatment at home. Technological advancements and the miniaturization of healthcare products drive the demand for home healthcare devices, making them more accessible and user-friendly.

Regional Insights

North America smart wearable ECG monitors held the largest revenue share of in 2024 driven by increasing adoption of digital health technologies, rising prevalence of cardiovascular diseases, and a strong focus on preventive healthcare. The market's expansion is further propelled by the integration of wearable ECG devices into telehealth platforms and electronic health records (EHRs), facilitating real-time data sharing and remote patient monitoring. This integration supports early detection of cardiac anomalies and enhances patient engagement in managing their health. For instance, a proof-of-concept study by National Library of Medicine demonstrated that data of KardiaMobile ECG developed by AliveCor U.S. based medical device company, could be seamlessly uploaded to the KardiaPro platform and embedded into the EPIC EHR system, streamlining clinician workflows and improving real-time arrhythmia detection.

U.S. Smart Wearable ECG Monitors Market

The U.S. smart wearable ECG monitors market is driven by its strong emphasis on innovation and early adoption of cutting-edge technologies. Healthcare providers and consumers increasingly rely on wearable ECG devices for proactive cardiac care, supported by extensive clinical validation and integration with major electronic health record systems. The presence of prominent technology firms and startups fosters a competitive landscape, driving continuous product enhancements.

Europe Smart Wearable ECG Monitors Market

Smart wearable ECG monitors market in Europeis anticipated to grow significantly over the forecast period. This growth is supported by the integration of wearable ECG devices into telehealth platforms and electronic health records (EHRs), facilitating real-time data sharing and remote patient monitoring. The market is further driven by presence of key players such as Philips Healthcare, GE Healthcare, and Medtronic, who continue to innovate and offer devices with advanced features like AI-powered analytics and user-friendly interfaces.

Smart wearable ECG monitors market in U.K.is influenced by increasing prevalence of cardiovascular diseases and a shift towards preventive healthcare. Wearable ECG devices, such as patches, chest straps, and smartwatches, offer non-invasive, continuous monitoring, enabling early detection of heart abnormalities and reducing the need for frequent hospital visits. In addition, e expansion of telehealth services and remote patient monitoring is further propelling adoption. For instance, QardioCore, a wireless wearable ECG chest strap, received CE Mark approval, allowing it to enter the UK market with its ability to continuously monitors multiple vital signs without wires or adhesive patches, seamlessly integrating with mobile apps for real-time data sharing with healthcare professionals.

Smart wearable ECG monitors market in Germany is driven by his can be attributed to increasing geriatric population, high healthcare expenditure, availability of advanced devices, and growing adoption of ECG management systems. As of 2023, approximately 22.8% of Germany's population was aged 65 and above, with projections indicating that this proportion will continue to rise in the coming decades. According to WHO, Germany ranks eighth in rate of heart disease-related deaths among OECD countries. In response to these challenges, the German healthcare system is increasingly integrating advanced diagnostic tools, including smart wearable ECG monitors, to facilitate early detection and management of cardiac conditions.

Asia Pacific Smart Wearable ECG Monitors Market

The Asia Pacific smart wearable ECG monitors market is experiencing rapid growth, driven by an aging population, increasing prevalence of cardiovascular diseases, and rising healthcare expenditures. The region's diverse demographic, coupled with advancements in wearable technology, has led to a surge in the adoption of devices that offer continuous cardiac monitoring. Countries like China, Japan, and India are at the forefront, with initiatives aimed at integrating digital health solutions into mainstream healthcare systems.

Country’s aging population, increasing prevalence of cardiovascular diseases, and rising healthcare expenditures are the factors contributing to growth of smart wearable ECG monitors market in China. For instance, according to the World Health Organization, by 2040 approximately 402 million people, or 28% of the total population of China, will be over the age of 60. This demographic shift, combined with growing health awareness and government initiatives like the "Healthy China 2030" plan, is driving the adoption of advanced wearable ECG devices for continuous cardiac monitoring and preventive care across the country.

The smart wearable ECG monitors market in India is witnessing rapid growth driven by increasing cardiovascular disease prevalence, growing health awareness, and rising disposable incomes. The expanding middle-class population and improving healthcare infrastructure are fostering greater adoption of advanced wearable health technologies. In addition, initiatives like the National Digital Health Mission (NDHM) aim to digitize healthcare records and promote telemedicine, creating a supportive environment for wearable ECG devices. Government efforts to improve rural healthcare access and growing demand for remote patient monitoring solutions are further accelerating market growth, as consumers seek convenient, real-time cardiac health tracking outside traditional clinical settings.

The Latin America smart wearable ECG monitors market is expanding steadily, driven by increasing awareness of cardiovascular health and a rising burden of heart-related diseases across the region. Limited access to traditional healthcare facilities in rural and underserved areas has fueled demand for portable and easy-to-use wearable ECG devices that enable remote monitoring and timely diagnosis.

Middle East & Africa Smart Wearable ECG Monitors Market

The Middle East & Africa smart wearable ECG monitors market is gaining momentum due to rising cardiovascular disease prevalence and increasing government focus on improving healthcare infrastructure. The region’s growing investments in digital health and telemedicine, particularly in countries such as the UAE, Saudi Arabia, and South Africa, are facilitating the adoption of wearable health technologies.

Key Smart Wearable ECG Monitors Company Insights

The market is moderately concentrated, with many small and large players operating in this space. This leads to intense competition between smaller players to sustain their position. Strategies such as new product launches and partnerships are playing a key role in propelling the market growth.

Recent Developments

• In April 2025, HeartcoR Solutions partnered with Wellysis, digital healthcare company specializing in wearable electrocardiogram (ECG) technology. By this partnership HeartcoR Solutions gained rights to use the Wellysis S-Patch device in clinical trials.

• In November 2024, SmartCardia received FDA clearance for Mobile Outpatient Cardiac Telemetry for ECG monitoring patch and cloud platform. SmartCardia’s ECG monitoring patch is 7-lead live patch which is easy-to-wear, cable-free, waterproof.

• In September 2023, iRhythm Technologies, Inc. launched next-generation Zio monitors, the smallest, lightest, and thinnest cardiac monitors. This is a AI integrated prescription-only ECG monitors.

• In May 2023, Vivalink, launched multi-parameter wearable electrocardiogram (ECG) patch. This patch offers continuous 14-day live stream capabilities.

Smart Wearable ECG Monitors Market Report Scope

Global Smart Wearable ECG Monitors Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global smart wearable ECG monitorsmarket report based on type, distribution channel, end use and regions.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Chest Straps

  • Patches

• Distribution Channel Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmacies

  • Online Channel

  • Direct-to-Consumer (DTC)

  • Others

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Clinics

  • Home Care

  • Others (Sports, Fitness Centers, Assisted Living)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait