NextGen Smartphone‐Enabled Medical Devices Market to Reach US$ 89.15 B by 2033: AI, Wearables, Remote Monitoring & Telehealth Driving Growth

Market Size and Growth

Global smartphone enabled medical devices market reached US$ 22.76 billion in 2024 and is expected to reach US$ 89.15 billion by 2033, growing at a CAGR of 14.6% during the forecast period 2025-2033.

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Key Development:

United States: Recent Industry Developments

✅ In November 2025, Tandem Diabetes Care received FDA clearance for the Android version of its Tandem Mobi mobile app, enabling users to manage their insulin delivery directly from compatible smartphones.

✅ In November 2025, the FDA published draft discussion points to regulate digital mental health medical devices, especially generative‐AI smartphone apps, to define benefit‐risk evidence requirements over their full life cycle.

✅ In November 2025, GlobalMed launched its Mobile Medical Unit, a rugged field-deployable telemedicine center that leverages real-time video, secure smartphone-linked triage, and virtual consultations for emergencies and remote care.

✅ In October 2025, the FDA issued a Request for Public Comment on evaluating AI‐enabled medical devices in real‐world use - seeking input on how to measure performance drift and maintain safety and efficacy over the device lifecycle.

Japan: Recent Industry Developments

✅ In November 2025, at the R&D Forum, NTT demonstrated a remote-touch examination system where a physician instructs a nurse via AR‐goggles, and the nurse's touch is relayed back with force feedback to the doctor's device.

✅ In October 2025, at the 45th Japanese Medical Informatics Conference, Sony showcased its Xperia 10 VII smartphone configured for hospital use, plus a portable data transmitter to stream clinical video.

✅ In October 2025, Japan's Ministry of Internal Affairs & Communications (総務省) confirmed that LTE smartphones have no interference risk with implanted medical devices like pacemakers, following a recent national technical investigation.

✅ In September 2025, Kyocera exhibited its durable, disinfectable smartphones and tablets tailored for clinical pharmacy environments, enabling scanning (barcodes), NFC, and real-time data capture in drug dispensing.

Recent Mergers and Acquisitions:

United States: Recent M&A in Smartphone‐Enabled Medical Devices

✅ In November 2025, Empatica acquired PKG Health, integrating its Parkinson's‐monitoring movement‐disorder algorithms into Empatica's FDA‐cleared, smartphone‐connected wearable platform.

✅ In October 2025, ZS acquired Torrent Consulting, expanding healthcare and life‐sciences cloud implementations - a move that may strengthen its digital engagement platforms including remote‐monitoring tools.

✅ In October 2025, Blackstone and TPG announced an $18.3 billion deal to acquire Hologic, a company with diagnostics and imaging devices - potentially accelerating its digital health and connected‐device ambitions.

✅ In October 2025, Thermo Fisher Scientific agreed to acquire Clario for up to $9.4 billion, strengthening its clinical‐trial data and digital‐platform capability - relevant for mobile‐enabled patient‐data capture.

Japan: Recent M&A

✅ In July 2025, Kakehashi, a Japanese health‐tech company, acquired Noah Medical System, which provides pharmacy management systems and AI‐forecasting tools - pushing further into digital and smart care infrastructure.

✅ In March 2025, private equity firm KKR moved to acquire Topcon Corporation, a Tokyo‐based medical equipment maker known for its diagnostic and positioning devices, signaling consolidation in Japanese med‐gear.

✅ In mid‐2025, EY Japan reported increasing M&A activity in life‐science AI and smart medical-device firms, highlighting digital health platforms and smartphone‐device synergies as key targets.

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Key Players:

=> Apple Inc, Samsung Electronics, DexCom, Inc, Masimo Corporation, Sonova Holding AG, Oura Health Ltd, Beurer GmbH, Medtronic, Abbott Laboratories, and AliveCor, Inc, among others.

Key Segments:

By Product Type

Diagnostic devices lead with 35% share, driven by increasing adoption of point-of-care testing, lab diagnostics, and early disease detection technologies. Monitoring devices account for 28%, supported by continuous patient monitoring, wearable biosensors, and remote healthcare initiatives. Therapeutic devices hold 20%, fueled by rising use of medical devices for chronic disease management, rehabilitation, and treatment. Fitness and wellness devices represent 12%, reflecting growing consumer focus on health tracking and preventive care. Other devices make up 5%, catering to niche applications in research and specialized medical procedures.

By Application

Patient monitoring dominates with 32% share, driven by hospitals and home-based care adoption for critical and post-operative patients. Chronic disease management accounts for 28%, supported by the rising prevalence of diabetes, cardiovascular, and respiratory conditions. Fitness tracking represents 20%, fueled by wearable devices and wellness programs. Remote diagnostics hold 20%, reflecting the growing trend of telemedicine, virtual consultations, and home healthcare services.

By End-User

Hospitals and clinics lead with 50% share, driven by adoption of advanced diagnostic, monitoring, and therapeutic devices. Home care settings account for 30%, supported by remote patient monitoring, telehealth, and convenience-driven healthcare solutions. Fitness centers represent 20%, fueled by wearable wellness devices and preventive health programs.

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By Region

North America - 38% Share
North America leads with 38%, supported by advanced healthcare infrastructure, high adoption of digital health technologies, and strong regulatory support for medical devices.

Europe - 28% Share
Europe holds 28%, driven by healthcare modernization, preventive care initiatives, and increasing adoption of monitoring and diagnostic devices across Germany, U.K., France, Italy, and Spain.

Asia-Pacific - 23% Share
Asia-Pacific accounts for 23%, fueled by rising healthcare investments, expanding hospital networks, growing telemedicine adoption, and increasing prevalence of chronic diseases in China, India, Japan, and Australia.

South America - 6% Share
South America holds 6%, supported by improving healthcare infrastructure and adoption of home-based monitoring and fitness devices in Brazil, Argentina, and neighboring countries.

Middle East & Africa - 5% Share
The Middle East & Africa represent 5%, driven by emerging healthcare markets, increasing awareness of preventive care, and adoption of digital health solutions across hospitals and homecare settings.

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