Mobile ECG Devices Market Report Size Analysis:

The mobile ECG devices market size was valued at USD 2.9 billion in 2024 and is expected to reach USD 7.51 billion by 2032, growing at a CAGR of 11.17% over the forecast period 2025-2032.

Increased focus on advanced monitoring of cardiovascular health coupled with general acceptance of digital health systems, are some major factors expected to drive remarkable growth of the mobile ECG devices market throughout the forecast period.

For instance, the Centers for Disease Control and Prevention (CDC) reported that in 2022, heart disease continued to be the number-one cause of death in the US, being responsible for about 702,880 deaths, approximately 1 in 5 deaths.

This alarming statistic has triggered a strong government response, such as increasing capital for digital health infrastructure by the U.S. Department of Health and Human Services (HHS) and expanding Medicare coverage for remote patient monitoring (RPM). U.S. with a uniquely eye-catching mobile ECG device market share, the U.S. mobile ECG devices market was valued at USD 1.20 billion in 2024, and it’s expected to reach USD 2.77 billion by 2032 with a CAGR of 11.05% over the forecast period, due to the accelerated approval of creative mobile electrocardiogram devices, including wearable ECG monitors, portable ECG devices, and smartphone ECG devices by regulatory authorities, including the U.S. Food and Drug Administration (FDA), advanced cardiac arrhythmia detection and ambulatory ECG monitoring are now more easily available.

The increasing adoption of wireless ECG devices and home-based ECG monitoring systems, which have become indispensable tools for patients and healthcare professionals, defines the global mobile ECG devices market. The mobile ECG devices market growth has been greatly aided by the most recent government-backed projects, such as the Centers for Medicare & Medicaid Services (CMS) increasing reimbursement for remote ECG monitoring solutions.

Mobile ECG Devices Market Dynamics:

Drivers

Increasing Prevalence of Heart Disease and Telemedicine Adoption Fuel the Global Mobile ECG Device Use

The adoption of mobile ECG equipment is mostly driven by the rising frequency of heart-related diseases, as emphasized by the Centers for Disease Control and Prevention (CDC).  One in every five deaths in the United States in 2022 was from heart disease, accounting for 702,880 deaths alone. This concerning figure emphasizes how urgently early intervention techniques and good cardiac monitoring are needed.  Essential for the diagnosis of cardiac arrhythmias and myocardial infarction, mobile ECG monitors have evolved as a fundamental component of both preventive and continuous cardiac treatment. Particularly in the COVID-19 pandemic, the explosion in telemedicine and remote patient monitoring has hastened the incorporation of these devices into mainstream practice.

In response to this need, regulatory authorities, including the U.S. FDA, have approved emergency use authorizations for portable ECG devices, including AliveCor's KardiaMobile 6L in 2021, thus increasing remote cardiac monitoring access. Along with government campaigns supporting digital health, the cooperation between healthcare providers and technology companies is creating an environment whereby mobile ECG devices are progressively acknowledged as indispensable for continuous cardiac care, especially in high-risk and elderly populations. These advances represent a global shift toward easily available, technologically advanced healthcare solutions with early identification and patient empowerment priority.

Restraints

Security and Privacy Concerns Undermine User Confidence and Limit Integration of Mobile ECG Devices

A major obstacle to the general use of mobile ECG devices is still significant privacy and security issues. The safety of delicate health data gathered, transferred, and kept on these devices worries patients and medical experts more and more. Though mobile ECG technology has clinical advantages, people's fear of illegal access, data breaches, and misuse of personal health information can discourage them from accepting it. Strict compliance to safeguard patient health information is mandated by regulatory systems, including the Health Insurance Portability and Accountability Act (HIPAA) in the United States, which forces manufacturers to apply strong encryption, access restrictions, and safe data transmission techniques.

However, even with these measures, the perception of risk persists, particularly as the volume and complexity of digital health data grow. Because both patients and doctors may be reluctant to depend on data gathered outside conventional healthcare environments, this lack of user confidence can restrict the value of remote patient monitoring and telehealth services.  The mobile ECG devices market has to solve privacy and security issues as regulatory scrutiny gets more intense and cyber threats change if it is to fully improve cardiac care.

Mobile ECG Devices MarketSegmentation Analysis

By modality

With a 42% revenue share in 2024, handheld ECG devices dominated the market and are expected to rise at a significant CAGR over the forecast period. Their portability, simple design, and fit for both clinical and domestic environments help to explain their success.  Demand for healthcare wearable gadgets and portable cardiac monitoring solutions is still driven by the aging population, as stated by the U.S. Census Bureau and foreign agencies. With the American Telemedicine Association expecting a notable rise in telehealth visits with mobile cardiac monitoring devices in 2024, handheld and wireless ECG devices have become essential for telemedicine integration. For instance, launched in January 2025, HeartBeam's FDA-cleared device is presently under trial in the Early Access Program, confirming its clinical relevance and encouraging the expansion of the market.

By end use

With a 47% revenue share in 2024, hospitals and diagnostic centers led the market, depending on FDA-approved ECG equipment for high-precision diagnoses and ongoing monitoring. Government funding in digital health and the acceptance of remote ECG monitoring systems help these organizations. Major alliances, including those involving Medtronic, Philips, and top hospital networks, have sped the introduction of superior mobile ECG technology in 2024. Driven by improved CMS reimbursement for RPM, the increasing prevalence of chronic heart problems, and the growing inclination for patient-centric, home-based treatment, the homecare industry is positioned for the fastest CAGR.  Further driving this trend is the FDA's clearance of new home-use ECG devices, including cloud-connected ones with artificial intelligence. Emphasizing the increasing acceptance of home-based ECG monitoring systems, CMS noted a 20% year-over-year rise in RPM claims for cardiovascular monitoring in 2024.

Regional Analysis

With the U.S. having a 49% market share in 2024, the North America region dominated the global market. Strong telemedicine integration, advanced healthcare infrastructure, and a high frequency of cardiovascular disorders define this leadership.

For instance, the Centers for Disease Control and Prevention (CDC) noted 702,880 heart disease deaths in the United States in 2022, highlighting the urgent need for improved cardiac monitoring systems.

Strong government support also helps this dominance; the FDA's fast clearance of creative mobile ECG and wearable ECG monitors and the Centers for Medicare & Medicaid Services (CMS) increased payment for remote patient monitoring (RPM) benefit show. Major mobile ECG device companies such as Medtronic and AliveCor have headquarters here, therefore encouraging technological innovation and market penetration.

Asia-Pacific is the fastest-growing region, projected to register a CAGR of 11.9% through 2025-2032. The fast-aging population of the region, growing knowledge of cardiovascular health, and growing acceptance of digital health technologies all help to drive this growth.  Over 10 million cardiovascular cases in Asia-Pacific in 2023, according to the World Health Organization (WHO), China and India are aggressively investing in telehealth and digital infrastructure; for instance, the Ministry of Health of India started a national telecardiology project in late 2023, distributing mobile ECG devices in rural clinics to increase cardiac care access. To further speed market development, the Asian Development Bank also forecasts digital health investments in the area to reach USD 20 billion by 2025.

Europe is experiencing steady growth, driven by robust regulatory systems and innovative digital health projects. The European Commission set aside €250 million in 2024 for wearable ECG monitors and cloud-based ECG data systems, therefore supporting digital health infrastructure.

Mobile ECG Devices Market Key Players

The key Mobile ECG Devices companies are Emay, Nihon Kohden Corporation, Medtronic, Omron, iRhythm Technologies, Inc., SmartCardia Inc., New York Plastic Surgical Group, Koninklijke Philips N.V., Dr Trust, GE Healthcare, VivaLNK, Inc., and others.

Recent Developments in the Mobile ECG Devices Market

• HeartBeam, Inc.'s portable, cable-free ambulatory ECG device got FDA 510(k) certification in January 2025, therefore transforming at-home cardiac monitoring.

• U.S. CMS enhanced payment for remote patient monitoring in 2024, therefore directly encouraging the acceptance of home-based ECG monitoring systems and wireless ECG devices.