U.S. Smart Wearable ECG Monitors Market Size, Share & Trends Analysis Report By Type (Chest Straps, Patches), By Distribution Channel (Pharmacies, Online Channel), By End-use, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The U.S. smart wearable ECG monitors market size was estimated at USD 586.91 million in 2024 and is expected to grow at a CAGR of 8.39% from 2025 to 2030. Rising concerns about cardiovascular diseases and obesity contribute to the adoption of wearable products such as electrocardiogram (ECG) monitors. A wearable ECG patch incorporates an electrocardiography sensor and an accelerometer to monitor and capture physiological data. Moreover, advancements in ECG technology, including the rise of portable and handheld devices, are significantly driving market growth. 

Smart ECG monitoring is experiencing a significant rise in clinical trials as healthcare providers seek more efficient and accurate patterns to detect and manage heart conditions. These trials evaluate advanced wearable ECG devices and smartphone-integrated technologies that continuously monitor cardiac activity in real-time. By leveraging artificial intelligence (AI) and machine learning, smart ECG systems aim to improve early diagnosis of arrhythmias, atrial fibrillation, and other cardiac abnormalities, ultimately enhancing patient outcomes. For instance, clinical trial findings published in Heart Rhythm in June 2021 reveal that continuous electrocardiography (ECG) monitors, which rely on human oversight, are better at accurately identifying significant arrhythmias than mobile cardiac telemetry (MCT). The results show that ECG monitors are over 200% more effective in detecting these arrhythmias. The growing number of clinical studies highlights the increasing belief in these technologies to revolutionize cardiovascular care through more accessible, non-invasive, personalized monitoring solutions.

As telemedicine continues to grow and the demand for remote patient monitoring increases, contemporary ECG machines have become essential tools in healthcare. These devices now feature wireless connectivity , enabling healthcare professionals to monitor their patients' heart activity remotely. Patients utilize portable ECG monitors, such as cardiac event monitors, that continuously collect and transmit data to their healthcare providers. This instantaneous monitoring allows doctors to identify irregularities and initiate timely action when necessary. For instance, in April 2025, researchers Zheng Yan and Sicheng Chen from the University of Missouri introduced a starfish-shaped wearable gadget that monitors heart health in real time. The device easily connects to a smartphone app, offering users health insights and aiding in the detection of potential heart issues. Furthermore, remote ECG monitoring is especially beneficial for those living in rural areas or patients with mobility challenges. With these advancements, such individuals are able to access quality healthcare without needing to physically visit medical facilities. Modern ECG machines have thus significantly transformed patient care, enhancing accessibility and convenience for people worldwide. Thus, such factors are anticipated to boost the market growth.

Increasing adoption of technologically advanced smart wearable ECG monitors, particularly among individuals with cardiovascular conditions. These devices, which include smartwatches and portable ECG monitors, offer continuous, real-time heart monitoring outside of clinical settings, enabling early detection of arrhythmias, atrial fibrillation, and other cardiac abnormalities. This shift toward personalized and preventive healthcare is mainly due to the rising global prevalence of heart diseases, including hypertension and coronary artery disease. Below is the list of trending smart wearable ECG monitors

Case Study: Early Detection of Atrial Fibrillation Using the Cardea SOLO Wearable ECG Sensor

Background:

Atrial fibrillation (AF) is a prevalent yet frequently underdiagnosed heart rhythm disorder that considerably elevates the risk of stroke and other cardiovascular issues. Conventional diagnostic tools, such as 24- to 48-hour Holter monitors, do not effectively detect intermittent or late-onset episodes. To fill this diagnostic gap, smart wearable ECG monitors, such as the Cardea SOLO, are increasingly utilized in clinical settings.

Clinical Scenario:

A 77-year-old woman presented to a cardiology clinic with symptoms of dizziness and low blood pressure—indicators often linked to irregular heart rhythms. Considering her age and these symptoms, the clinical team suspected she was experiencing intermittent atrial fibrillation. It required a dependable method to capture episodes beyond the standard Holter monitor timeframe.

Technology Applied:

The patient was fitted with the Cardea SOLO wearable ECG sensor, a single-use, wire-free device for prolonged ambulatory monitoring. This device eliminates the need for leads or follow-up visits for data retrieval, making it convenient for patients and healthcare providers. It continuously recorded ECG data for six days, which was subsequently analyzed using automated algorithms and interpreted by medical professionals.

Key Findings:

On day five of monitoring, the Cardea SOLO captured an episode of atrial fibrillation, confirming the suspected diagnosis. Conventional short-duration monitors have not detected this critical event. The system delivered 99.4% analyzable ECG data, demonstrating its reliability and effectiveness for long-term cardiac monitoring.

Outcome and Impact:

Due to the early diagnosis enabled by the Cardea SOLO, the clinical team was able to initiate timely anticoagulation therapy, potentially reducing the patient’s risk of stroke and other complications. The convenience and ease of in-clinic application improved patient compliance and clinic workflow efficiency.

Conclusion:

This case highlights the transformative role of wearable ECG monitors such as the Cardea SOLO in modern cardiology. By offering extended, high-quality monitoring in a patient-friendly format, such devices significantly enhance the ability to detect intermittent arrhythmias, leading to earlier intervention and improved patient outcomes.

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 & collaboration 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 product expansion is experiencing rapid growth.

The market is characterized by a high degree of innovation owing to AI-based diagnostics and seamless integration with telehealth and electronic health records (EHR). For instance, in March 2024, Ambiq, a semiconductor developer, partnered with Smartaly, an electronics designer, to develop a handheld electrocardiogram (ECG) monitor that is both energy-efficient and intelligent. This device utilizes the Apollo3 SoC, which has integrated AI capabilities, to continuously monitor and detect the heart's electrical activity for up to a week on a single battery charge.

The market is characterized by a medium level of merger and acquisition (M&A) activity, facilitating access to complementary expertise, technologies, and distribution channels to capture a larger market share. For instance, in May 2024, WearLinq, a company  specializing in wearable health monitoring and diagnostic solutions, acquired AMI Cardiac Monitoring, LLC, a diagnostic testing facility. This strategic move is anticipated to enhance WearLinq’s ability to deliver comprehensive clinical services nationwide across all 50 states of the U.S. It allows more patients to access its eWave 6-lead wearable ECG monitor, which has recently obtained FDA 510(k) clearance.

Regulations significantly impact the U.S. smart wearable ECG monitors industry by shaping compliance requirements and driving the adoption of technology solutions. In the U.S., smart ECG monitors used for medical purposes are regulated by the U.S. Food and Drug Administration (FDA). These devices must undergo FDA clearance or approval to market and use in the U.S. The FDA's regulatory process ensures that these devices are safe and effective for their intended use.

Several market players are expanding their business by launching new solutions in the market to expand their product portfolio. For instance, in December 2024, HeartBeam, Inc., a MedTech company, obtained U.S. FDA 510(k) clearance for its HeartBeam system, designed for thorough arrhythmia evaluation. This advanced electrocardiogram (ECG) system boasts a cable-free design and a compact form factor, similar in size to a credit card. It captures heart signals across three different directions, delivering detailed and actionable insights regarding heart health.

Type Insights

By type, the patches segment dominated the market with the largest revenue share of 66.61% in 2024. Smart ECG patches integrate advanced biosensors, wireless communication, and cloud connectivity to provide real-time cardiac monitoring. These patches are often used in outpatient settings to detect arrhythmias, atrial fibrillation, and other heart rhythm abnormalities over extended periods ranging from a few days to several weeks. Key players' rising focus on the innovation and launch of smart ECG patches and rising FDA approval for smart ECG patches contribute to the segment's growth. For instance, in November 2024, SmartCardia, the wearable technology company, obtained U.S. FDA cle arance for its mobile outpatient cardiac telemetry (OCT/MCT) system, which features a seven-lead ECG monitoring patch integrated with a cloud-based platform. This clearance allows for real-time remote monitoring of ECG data and instant alerts to clinicians in the event of significant arrhythmias. The system supports continuous cardiac monitoring for up to 14 days.

The chest straps segment is anticipated to witness the fastest CAGR growth over the forecast period. Smart ECG chest straps are equipped with advanced biosensors and Bluetooth connectivity, enabling seamless integration with mobile apps and cloud platforms for remote data analysis and health tracking. The growing adoption of digital health solutions and wearable fitness technologies further strengthens the demand for chest strap ECG monitors. For instance, in January 2025, Norav Medical, a medical equipment manufacturer , introduced a Chest Strap ECG, a flexible, sticker-free solution for long-term monitoring. The following are the benefits of the Chest Strap ECG,

• Comfort and versatility

• Flexible monitoring durations

• Efficient for clinics

• Seamless integration

Distribution Channel Insights

By distribution channel, the pharmacies segment dominated the market with the largest revenue share of 39.50% in 2024. Community and retail pharmacies are evolving into community health hubs, playing a growing role in chronic disease management programs, particularly for cardiovascular diseases. As part of these programs, pharmacists often recommend or directly dispense monitoring devices, including wearable ECG monitors, to help patients track heart conditions such as atrial fibrillation or arrhythmias in real time. This proactive engagement directly fuels demand for ECG monitors through this segment channel.

The online channel segment is anticipated to witness the fastest CAGR growth over the forecast period, owing to changing consumer preferences, digitalization of healthcare, and evolving retail ecosystems. Online platforms allow individuals to browse, compare, and purchase smart ECG monitors from the comfort of their homes, eliminating the need for physical store visits. This especially appeals to tech-savvy and health-conscious consumers, elderly individuals, or those with mobility constraints who benefit from remote access to essential health monitoring devices. Furthermore, retail pharmacies invest in digital platforms and e-commerce capabilities, enabling online purchase of smart ECG monitors and home delivery. Thus, such factors are expected to boost the market growth over the forecast period.

End Use Insights

By end use, the hospitals segment dominated the market with a share of 44.25% in 2024. Several types of smart ECG monitors are used in U.S. hospitals, including those from GE HealthCare, Mindray, Philips, and Nihon Kohden. These monitors typically include multiparameter bedside systems that analyze ECG data and trigger alarms for high-severity arrhythmias. Furthermore, according to the National Institutes of Health (NIH), several specialized devices, such as the AliveCor KardiaMobile, use smartphone connectivity and an app to transmit ECG data. Thus, such a rise in the utilization of smart ECG monitors in hospitals fuels the segment growth. 

The home care segment is anticipated to witness the fastest CAGR growth over the forecast period. Home-based smart ECG monitors have emerged as a viable alternative to traditional hospital ECG tests. These solutions prioritize patient convenience and leverage technological advancements. They allow patients to perform ECG monitoring in the comfort of their homes, enhancing cardiac care conveniently. Advancements in sensor technology, miniaturization, and wireless connectivity have significantly improved the accuracy, usability, and affordability of smart wearable ECG monitors. These innovations make the devices more accessible to a broader population, including elderly patients and those with chronic cardiac conditions. The increasing awareness and acceptance of digital health tools among consumers further propel the adoption of homecare ECG monitoring solutions, enabling a more patient-centric approach to cardiac health management.

Key U.S. Smart Wearable ECG Monitors Company Insights

Key participants in the U.S. smart Wearable ECG monitors market are focusing on developing innovative business growth strategies in the form of product portfolio expansions, partnerships & collaborations, mergers & acquisitions, and business footprint expansions.

Recent Developments

• In April 2024, HeartBeam, Inc., a MedTech company , partnered with AccurKardia, a provider of ECG-based diagnostic technology. This partnership aims to improve access to cardiac monitoring solutions and integrate AccurKardia's FDA-cleared ECG analysis software, AccurECG, into HeartBeam's devices.

• In April 2025, HeartcoR Solutions , an ECG core lab performing cardiac safety studies for the medical device, pharmaceutical, and CRO industries, partnered with Wellysis, a company focused on digital healthcare and wearable electrocardiogram (ECG) technology. This partnership grants HeartcoR exclusive rights to utilize the Wellysis S-Patch device in clinical trials.

 U.S. Smart Wearable ECG Monitors Market Report Scope

U.S. Smart Wearable ECG Monitors Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis on industry trends in each of the sub segments from 2018 to 2030. For the purpose of this study, Grand View Research, Inc. has segmented the U.S. smart wearable ECG monitors market report on the basis of type, distribution channel, and end use:

• 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