United States Smartphone Enabled Medical Devices Market 2025 | Growth Drivers, Key Players & Opportunities

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.

Key Development:

United States: Recent Industry Developments

✅ In September 2025, Butterfly Network raised US$250 million in Series D to scale its pocket-sized ultrasound device that plugs into an iPhone, aiming to make high-quality imaging more accessible.

✅ In August 2025, Noctrix Health secured US$33.5 million (equity + debt) to advance commercialization of its Nidra wearable, a non-invasive neuromodulation therapy targeting Restless Legs Syndrome with smartphone-enabled monitoring.

✅ In July 2025, SoundHealth launched its Android app for the FDA-approved SONU Band, turning a selfie into CT-accurate skeletal data via smartphone to treat rhinitis and allergy symptoms without drugs.

Japan: Recent Industry Developments

✅ In September 2025, Japan rolled out smartphone health insurance cards via its My Number system, allowing compatible smartphones to serve as digital health insurance cards while subsidizing card reader installs in medical facilities.

✅ In January 2025, Japan's Ministry of Health announced financial support for medical institutions and pharmacies to adopt digital My Number health insurance cards using smartphone screen readers, accelerating the elimination of traditional cards.

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Smartphone-Enabled Medical Devices are healthcare tools that connect with smartphones to monitor, diagnose, or manage health conditions. By integrating sensors, apps, and wireless connectivity, they enable real-time data collection, remote patient monitoring, and personalized healthcare, improving accessibility and efficiency in modern medical practice.

Recent Mergers and Acquisitions

✅ In July 2025, Samsung Electronics acquired Xealth (USA), a digital health platform used by over 500 U.S. hospitals, to integrate its wearable technologies and mobile health services.

✅ In July 2025, Tigermed completed the acquisition of Micron, Inc. (Japan), a CRO specializing in medical imaging and trial imaging services, strengthening smartphone-enabled diagnostics and imaging workflows.

✅ In July 2025, Nihon Kohden acquired a majority stake (~71.4%) in NeuroAdvanced Corp., parent of Ad-Tech Medical Instrument, expanding its neurology and monitoring device portfolio.

✅ In March 2025, KKR moved toward acquiring Topcon (Japan), a medical gear and eyecare equipment maker, reinforcing its position in healthcare and digital device ecosystems.

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.

Growth Forecast Projected:

The Global Smartphone Enabled Medical Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2023, 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 Smartphone Enabled Medical 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: Diagnostic Devices, Monitoring Devices, Therapeutic Devices, Fitness and Wellness Devices, Others

By Application: Patient Monitoring, Chronic Disease Management, Fitness Tracking, Remote Diagnostics

By End User: Hospitals and Clinics, Home Care Settings, Fitness Centers

Regional Analysis for Smartphone Enabled Medical 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 Smartphone Enabled Medical 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 Smartphone Enabled Medical 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 Smartphone Enabled Medical Devices Market?

A: In 2024, the Smartphone Enabled Medical Devices Market was valued at US$ 22.76 billion , reflecting its strong industry presence.

Q2: How large is the Smartphone Enabled Medical Devices Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Smartphone Enabled Medical Devices Market will grow to around US$ 89.15 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Smartphone Enabled Medical Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 14.6% during the forecast period from 2025 to 2033.

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