DelveInsight’s “Wearable Medical Devices -Market Insights, Competitive Landscape and Market Forecast - 2032” report delivers a comprehensive analysis of the wearable medical devices market globally.
Key Takeaways
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Market size projection: As per DelveInsight's analysis, the wearable medical devices market is expected to surge significantly at a CAGR of 13.67% during the forecast period from 2025 to 2032.
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Market segmentation: The report provides comprehensive wearable medical devices market segmentation analysis across device types including diagnostic and monitoring devices (vital sign monitoring devices, sleep monitoring devices, electrocardiographs fetal and obstetric devices, neuromonitoring devices) and therapeutic devices (pain management devices, rehabilitation devices, respiratory therapy devices).
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Key companies: Leading wearable medical devices companies include Koninklijke Philips N.V., Omron Corporation, Medtronic Canada, Dexcom Inc., Masimo, iRhythm Technologies Inc., CONTEC MEDICAL SYSTEMS CO., LTD., MediBioSense Ltd, VitalConnect, ten3T Healthcare Pvt. Ltd., Verily Life Sciences LLC, Biobeat, Biotricity, iHealth Labs Inc, VivaLNK Inc., Garmin Ltd, Intelesens Ltd, MINTTIHEALTH, Withings, and Fitbit Health Solutions, among others.
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In July 2025, the FDA issued a warning letter to WHOOP, Inc., regarding the marketing of its Blood Pressure Insights (BPI) feature. This development highlights the ongoing regulatory scrutiny of wearable devices that make medical claims without proper FDA clearance.
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The FDA updated its sensor-based digital health technology (sDHT) medical device list in July 2025, providing transparency to healthcare providers and patients about FDA-authorized wearable medical devices.
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In May 2025, Osteoboost Health announced the nationwide availability of Osteoboost across the US, the first FDA-cleared prescription medical device for low bone density. The device received Class II FDA clearance through the De Novo pathway and was designated as a Breakthrough Device by the FDA.
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The integration of artificial intelligence with wearables is becoming more prominent in 2025 clinical trials. AI is being used to manage the unprecedented volumes of clinical trial data generated by wearables and improve the overall quality of outputs.
Discover recent advancements in the Wearable Medical Devices landscape @ Wearable Medical Devices Recent Developments.
Wearable Medical Devices Market Dynamics
The global wearable medical devices market is experiencing robust growth momentum driven by several compelling factors. The market is witnessing positive growth primarily owing to the rising prevalence of various chronic diseases such as cardiovascular conditions, diabetes, and pain-related disorders.
The current wearable medical devices market size projections indicate steady expansion through 2032, with the market expected to maintain a compound annual growth rate of 13.67% during the forecast period from 2025 to 2032. This growth trajectory reflects the increasing integration of wearable technology into mainstream healthcare delivery systems.
North America is expected to dominate the overall wearable medical devices market, attributed to the growing prevalence of chronic diseases, surging elderly population burden, increasing unhealthy lifestyle patterns, and increasing regulatory approval for wearable health devices
The market expansion is further influenced by demographic shifts, particularly the rising burden of the geriatric population prone to various chronic diseases across the globe. According to DelveInsight’s report, people aged 60 years and beyond will double from 12-22% and reach 2.1 billion by 2050. Furthermore, by 2030, one out of every six people globally will be aged 60 years or beyond, with the number of people aged 80 years or above expected to triple between 2020 and 2050, reaching approximately 430 million.
The wearable medical devices development shows robust pipeline activity across multiple device categories. The electrocardiographs fetal and obstetric devices segment is expected to hold significant revenue share, attributed to growing advantages and applications, along with surging product approvals and launches by key manufacturers.
The wearable medical devices competitive landscape demonstrates active industry participation with strategic collaborations, acquisitions, and product launches. The COVID-19 pandemic has particularly accelerated market adoption, increasing awareness about physical fitness globally and surging demand for monitoring devices, including fitness monitors, cardiac monitors, pulse oximeters, respiratory monitors, and blood pressure monitors.
The wearable medical devices market unmet needs and opportunities include navigating regulatory approval processes while capitalizing on increasing regulatory acceptance for wearable medical technology. The market benefits from growing awareness about fitness and physical activity, presenting significant opportunities for expansion across therapeutic and diagnostic applications.
The wearable medical devices future market outlook remains highly positive, with growth drivers including technological advancement, expanding applications in remote patient monitoring, increasing healthcare digitization, and growing consumer acceptance of wearable health technologies. The market is expected to benefit from continued product innovation, strategic partnerships, and expanding geographic reach during the forecast period.
Download the Wearable Medical Devices Market report to understand which factors are driving the therapeutic market @ Wearable Medical Devices Market Trends.
Wearable Medical Devices Potential Patient Pool
Delveinsight’s report addresses the growing global burden of chronic diseases that drive demand for wearable medical devices. Key factors include the aging population demographics and chronic disease prevalence.
Patient Pool segmentation:
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Geriatric population (60+ years): Expected to double from 12-22% by 2050.
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Adults aged 45-64 years: 9.6% reported chronic heart disease or stroke diagnosis in 2023 in the US alone.
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Overall chronic disease burden: 6 in 10 adults in the United States have chronic diseases, with 4 in 10 having two or more chronic conditions.
Discover evolving trends in the Wearable Medical Devices patient pool forecasts @ Wearable Medical Devices Patient Pool Analysis.
Key Wearable Medical Devices Companies and Competitive Landscape
The wearable medical devices market represents a dynamic and rapidly evolving landscape characterized by diverse clinical applications and robust regulatory activity. Current treatment paradigms increasingly incorporate wearable technologies across diagnostic monitoring, therapeutic intervention, and preventive healthcare management.
The wearable medical devices clinical pipeline activity demonstrates significant momentum across multiple development phases, with companies advancing innovative solutions for vital sign monitoring, sleep monitoring, electrocardiographic applications, fetal and obstetric monitoring, neuromonitoring, pain management, rehabilitation, and respiratory therapy. The development landscape shows particular strength in electrocardiograph fetal and obstetric devices, which are expected to maintain a significant market share due to their expanding applications and clinical advantages.
Key wearable medical devices manufacturers dominating the competitive landscape include Koninklijke Philips N.V. (wireless Avalon CL Fetal and Maternal Pod and Patch), Omron Corporation, Medtronic Canada, Dexcom Inc., Masimo, iRhythm Technologies Inc., CONTEC MEDICAL SYSTEMS CO., LTD., MediBioSense Ltd, VitalConnect, ten3T Healthcare Pvt. Ltd., Verily Life Sciences LLC, Biobeat (wearable remote patient monitoring solutions), Biotricity, iHealth Labs Inc, VivaLNK Inc. (Continuous ECG Platform), Garmin Ltd, Intelesens Ltd, MINTTIHEALTH, Withings, and Fitbit Health Solutions.
Report’s commercial section highlights strategic collaborations and acquisition activity, exemplified by the Rockley Photonics-Medtronic partnership for next-generation wearable healthcare monitoring devices and Boston Scientific's acquisition of Preventice Solutions for enhanced remote patient monitoring capabilities. These partnerships reflect industry consolidation trends and the growing recognition of wearable technologies as integral components of comprehensive healthcare delivery systems.
Delve deeper into the major and specialised companies in the Wearable Medical Devices market @ Wearable Medical Devices Competitive Landscape.
Conclusion
DelveInsight's comprehensive analysis of the wearable medical devices market reveals a robust growth trajectory supported by demographic trends, technological advancement, and expanding clinical applications. With a projected CAGR of 13.67% through 2032, the market presents significant opportunities for stakeholders across the healthcare continuum. The convergence of aging population demographics, increasing chronic disease burden, and growing acceptance of remote monitoring solutions positions wearable medical devices as essential components of future healthcare delivery models. As regulatory frameworks continue to evolve and technological capabilities expand, the market is well-positioned for sustained growth and innovation throughout the forecast period.
Table of Contents
1. Wearable Medical Devices Market Report Introduction
2. Wearable Medical Devices Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Wearable Medical Devices Market Key Factors Analysis
6. Wearable Medical Devices Market Porter’s Five Forces Analysis
7. Wearable Medical Devices Market Assessment
8. Wearable Medical Devices Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us
About DelveInsight
DelveInsight is a leading business consulting and market research company focused on the healthcare and life sciences sectors, providing comprehensive market intelligence, competitive landscape analysis, and strategic insights to support decision-making across the pharmaceutical industry.
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