Press release
Portable Medical Devices Market is expected to reach USD 146.4 billion by 2030, growing at a CAGR of 11.3%, Diagnostic & Monitoring Devices segment holds 48.6% Market revenue. North America led 38.4% share of global market
portable medical devices
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United States: Key Industry Developments
✅ November 2025: Cybersecurity compliance costs have risen significantly for manufacturers, with cyber-insurance premiums climbing 15% year-on-year in 2025, which is impacting the pricing of connected portable devices.
✅ October 2025: Market reports highlighted an increasing trend toward integrating AI and advanced data analytics directly into portable medical devices to improve diagnostic accuracy and support sustainable healthcare practices.
✅ September 2025: Regulatory alignment was noted in the U.S., where the FDA has cleared the first over-the-counter continuous glucose monitor and is actively embracing the "Home as a Health Care Hub" concept to validate remote monitoring technologies.
United States: Recent Product Launches
✅ June 2025: SoundHealth received FDA approval for its new product, the
Sonu Band, an AI-enabled wearable designed to treat moderate-to-severe nasal congestion in adolescents.
✅ April 2025: Dexcom received FDA clearance for its , an extended-life continuous glucose monitoring product for adults aged 18 and over.
✅ January 2025: Withings gained FDA clearance for its , a connected device that links ocular microvascular imaging with hypertension detection to help identify early signs of organ damage.
Japan: Key Industry Developments
✅ November 2025: The Japanese market is emphasizing the integration of AI and IoT technologies into portable devices to support an aging population, creating high demand for products offering early diagnosis and constant health monitoring.
✅ July 2025: Omron announced plans to build its first manufacturing plant in Chennai, India, a strategic move to boost the production of blood pressure monitors and ECG devices to meet rising home-care demand across the broader Asian market, which includes Japan.
Recent FDA Approval:-
→ November 17, 2025: Synova Life Sciences, Inc. received 510(k) clearance for their Synova Wave Adipose Processing System, a portable system used for processing adipose tissue. This device facilitates point-of-care procedures.
→ October 22, 2025: RMedical Co., Ltd. received 510(k) clearance for the
Dr. PRP-30 Automated blood cell separator. This portable device is designed for the safe and rapid preparation of autologous platelet-rich plasma at a patient's point of care.
→ October 3, 2025: B.T.I. Biotechnology Institute, S.L. received 510(k) clearance for the ENDORET® Kit. This kit is another portable system designed for point-of-care preparation of autologous platelet-rich plasma to be mixed with bone grafts.
→ September 10, 2025: Haemonetics Corporation received 510(k) clearance for SafeTrace Tx® Software 5.0.0, a web-based electronic information system for blood transfusion management. While software, it is a key component for managing data across potentially portable LIS systems in a blood banking environment.
→ August 28, 2025: StemC Biyoteknoloji Anonim Sirketi received 510(k) clearance for the Exocube Set, which is a portable platelet and plasma separator for bone graft handling at the patient's point of care.
→ August 26, 2025: Bio-Rad Laboratories, Inc. received 510(k) clearance for the GeeniusTM HIV 1/2 Supplemental Assay. This assay is a single-use, immunochromatographic test for confirmation of HIV antibodies using various portable samples including fingerstick whole blood.
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Excel data sheet with numerous data points of global portable medical devices market-level with all segments.
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Market Segmenatation-
Segmentation by Product Type
→ Diagnostic & Monitoring Devices
This segment includes portable ECG machines, glucose monitors, blood pressure monitors, pulse oximeters, wearable health trackers, and portable imaging tools. These devices support continuous or remote monitoring, driven by rising chronic diseases and home-based care adoption.It is the largest product segment, holding around 48.6% of the market share in 2025.
→ Therapeutic Devices
This segment consists of portable ventilators, insulin pumps, TENS devices, infusion pumps, and respiratory therapy tools. Demand is supported by the shift toward outpatient treatment, elderly care needs, and chronic respiratory illness management.Therapeutic devices account for approximately 32.4% of the market in 2025.
→ Fitness & Wellness Devices
This includes smart wearables, activity trackers, portable body analyzers, and digital fitness tools aimed at preventive health and consumer wellness. Growing interest in health optimization and lifestyle tracking contributes to strong growth.Fitness & wellness devices hold about 19% of the market share in 2025.
Segmentation by Application
→ Home Healthcare
This segment covers portable devices used at home for chronic disease monitoring, elderly care, rehabilitation, and personal wellness tracking. Rising healthcare costs and the expansion of telehealth strengthen demand.It is the dominant application segment with an estimated 61.2% market share in 2025.
→ Hospitals & Clinics
Hospitals use portable medical devices for bedside monitoring, emergency response, point-of-care diagnostics, and mobility-based treatment support. Increased adoption of portable ultrasound, ventilators, and diagnostic tools drives this segment.This segment holds around 28.7% of the market in 2025.
→ Ambulatory Surgical Centers (ASCs) & Emergency Services
This includes devices used in ambulances, trauma units, and day-surgery centers to enable rapid diagnostics and mobility-based intervention. Growth is supported by the rising number of emergency cases, road accidents, and demand for fast diagnostic turnaround.This segment accounts for roughly 10.1% of the market in 2025.
Regional insights:-
1. North America - 38.4% Market Share
North America leads the global market due to strong adoption of home healthcare devices, a high prevalence of chronic diseases, and rapid integration of portable diagnostic and monitoring technologies. The presence of major manufacturers and growing telemedicine usage further strengthen regional dominance.
2. Europe - 27.1% Market Share
Europe holds the second-largest share, driven by aging populations, increased government support for digital health, and rising adoption of portable imaging and monitoring systems. Strong healthcare infrastructure and reimbursement policies also enhance market growth.
3. Asia-Pacific - 24.6% Market Share
Asia-Pacific is the fastest-growing region due to rapid expansion of healthcare facilities, rising consumer awareness, and growing demand for affordable portable devices in China, India, and Southeast Asia. The region benefits from increasing investment in homecare technologies and wearable health monitoring.
4. Latin America - 6.1% Market Share
Latin America shows rising adoption of portable diagnostic and therapeutic devices driven by growing urbanization, government health initiatives, and expanding private healthcare services. Market growth is supported by increasing chronic disease burden and demand for cost-effective solutions.
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Competitive Landscape
→ The major global players in the market include Lepu Medical Technology Co Ltd., Medtronic Plc., Becton Dickinson and Co, Omron Corporation, Koninklijke Philips NV, Hologic Inc., GE HealthCare Technologies Inc., Abbott Laboratories, Siemens Healthineers AG, FUJIFILM Holdings Corporation among others.
Key Developments
→ Mindray launched its first wireless, handheld ultrasound system called TE Air. TE Air features a wire-free design and compact size designed to easily fit into a pocket. It also offers high-level disinfection tolerance and flexible charging for extreme mobility.
→ Exo Imaging secured $200M in Series C financing aimed at commercializing its handheld ultrasound device and point-of-care workflow platform called Exo Works. The new funding also gives the Redwood City, California-based company over $320 million in total investments.
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