United States Wearable Heart Monitoring Devices Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Wearable Heart Monitoring Devices Market size reached US$ 2.58 Billion in 2024 and is expected to reach US$ 8.16 Billion by 2033, growing at a CAGR of 13.8% during the forecast period 2025-2033.

Key Development:

United States: Recent Industry Developments

✅ In July 2025, Cardiosense received U.S. FDA 510(k) clearance for its CardioTag wearable sensor that simultaneously captures ECG, PPG, and SCG signals, enabling advanced non-invasive assessment of cardiac function. The device supports early detection and continuous monitoring for patients at risk of arrhythmias.

✅ In July 2025, the FDA cleared a new wearable heart-monitoring device that captures multiple cardiac signals at once-expanding beyond traditional ECG to provide deeper cardiac insight for clinicians and remote monitoring.

✅ In May 2025, a major wearable cardiac device achieved CE mark approval for use across the European Union, signaling accelerating regulatory momentum and potential for adoption in U.S. telehealth and remote patient-monitoring programs.

✅ In March 2025, the FDA issued a warning letter to WHOOP regarding its "Blood Pressure Insights" feature within its wearable tracker, asserting that this feature classifies the product as a medical device requiring full regulatory approval, emphasizing compliance in wearable health devices.

Japan: Recent Industry Developments

✅ In May 2025, iRhythm Technologies launched its Zio® ECG Recording & Analysis System in Japan-a long-term continuous monitoring service leveraging AI for arrhythmia detection, with commercial availability through Japanese partners.

✅ In May 2025, Japan's market prepared for nationwide rollout of the Zio® system, targeting the large ambulatory cardiac-monitoring sector and supporting earlier regulatory approval.

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Key Players:

=> Medtronic, Qardio Inc, VitalConnect, ACS Diagnostics, medisana GmbH, iRhythm Inc., Koninklijke Philips N.V., VivaLNK, Inc., Abbott, SmartCardia Inc., among others.

Growth Forecast Projected:

The Global Heart Monitoring Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Heart Monitoring Devices Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Product Type: Chest Straps & Patches, Pulse Oximeters, Blood Pressure Monitors, Smartwatches, Others

➥ By Technology: Electric Pulse Based, Optical Technology Based

➥ By Application: Sports and Fitness, Medical Monitoring, Remote Patient Monitoring, Others

➥ By End-User: Hospitals, Homecare Settings, Cardiac Centers, Others

Regional Analysis for Heart Monitoring Devices Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Heart Monitoring Devices producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Heart Monitoring Devices revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Heart Monitoring Devices Market?

A: In 2024, the Heart Monitoring Devices Market was valued at US$ 2.58 Billion , reflecting its strong industry presence.

Q2: How large is the Heart Monitoring Devices Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Heart Monitoring Devices Market will grow to around US$ 8.16 Billion, demonstrating significant expansion.

Q3: What is the growth rate of the Heart Monitoring Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 13.8% during the forecast period from 2025 to 2033.

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