Wearable Heart Monitoring Devices Market is expected to reach US$ 8.16 Billion by 2033 | Top Companies - Medtronic, Qardio Inc, VitalConnect, ACS Diagnostics.

Market Size and Growth:

The 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. The Market is growing due to increasing prevalence of cardiovascular diseases and rising adoption of wearable technology for continuous heart health monitoring. According to DataM Intelligence Report.

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The Wearable Heart Monitoring Devices Market encompasses electronic devices designed to continuously track heart-related metrics, including heart rate, ECG, and arrhythmia detection. These wearable technologies, such as smartwatches, chest straps, and patches, provide real-time health insights, support preventive care, and enhance patient monitoring, facilitating early diagnosis, personalized treatment, and remote healthcare management across consumer and medical segments.

United States: Recent Developments of Wearable Heart Monitoring Devices Market

✅ September 2025: Biolinq received FDA De Novo classification for its Biolinq ShineTM, a forearm wearable patch advancing clinical-grade heart monitoring capabilities.​

✅ July 2025: Cardiosense secured FDA 510(k) clearance for the CardioTag wearable sensor, enabling simultaneous capture of ECG, PPG, and SCG signals for comprehensive non-invasive cardiac assessment.​

✅ November 2025: Reports highlighted ongoing market momentum with new wearable heart monitors expanding remote patient capabilities amid rising cardiovascular needs.

Europe: Recent Developments of Wearable Heart Monitoring Devices Market

✅ September 2025: Potential launch preparations for Apple Watch Ultra 3 with enhanced cardiac features like hypertension detection positioned for European markets.​

✅ May 2025: A major wearable cardiac device obtained CE Mark approval, accelerating regulatory pathways and adoption in EU telehealth programs.​

✅ October 2025: Integration of AI-driven wearable patches gained traction for chronic cardiac management across European healthcare systems.

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FDA Approvals & Clearances in 2025:

✅ In July 2025, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to CardioTag - the first multimodal wearable that simultaneously captures ECG, PPG and SCG signals.

✅ The clearance authorizes noninvasive measurement of cardiac electrical activity (ECG), blood‐flow/volume-related signals (PPG and SCG), as well as heart rate (HR) and pulse rate (PR).

✅ This represents a significant leap beyond typical wearables: by combining multiple sensing modalities, CardioTag enables richer cardiac‐function monitoring - not just rhythm detection.

Hexoskin Medical System (smart‐shirt wearable):

✅ In November 2025, Hexoskin received FDA 510(k) clearance for its smart‐shirt system that enables long-term continuous ECG and respiratory monitoring in ambulatory patients.

✅ The smart shirt captures ECG, respiratory rate, activity (and other signals) - bringing a comfortable, garment‐based alternative to traditional patch/Holter monitors.

✅ This clearance marks one of the first medical‐grade wearables cleared for long-term cardiopulmonary monitoring outside of hospital/clinic settings.

Jewel Patch Wearable Cardioverter Defibrillator (Patch‐WCD by Element Science):

✅ In May 2025, FDA approved this AI-enabled wearable defibrillator designed for patients at elevated risk of sudden cardiac arrest.

✅ The device monitors cardiac activity over extended periods and can deliver therapy (defibrillation) when necessary; the approval underscores regulatory acceptance of more advanced, active wearable cardiac interventions.

Major Players:

Key companies in the Wearable Heart Monitoring Devices market include:
Medtronic
Qardio Inc
VitalConnect
ACS Diagnostics
medisana GmbH
iRhythm Inc.
Koninklijke Philips N.V.
VivaLNK, Inc.
Abbott
SmartCardia Inc.

Segments Covered in the Wearable Heart Monitoring Devices Market:

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 Wearable 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)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Wearable Heart Monitoring Devices market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Wearable Heart Monitoring Devices Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Wearable Heart Monitoring Devices market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Wearable Heart Monitoring Devices Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Wearable Heart Monitoring Devices market?

➠ Who are the global key manufacturers of the Wearable Heart Monitoring Devices Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Wearable Heart Monitoring Devices market opportunities and threats faced by the vendors in the global Wearable Heart Monitoring Devices Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Wearable Heart Monitoring Devices market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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