Smartphone Enabled Medical Devices Market 2025 | Growth Drivers & Investment 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 Smartphone-Enabled Medical Device Developments

✅ In July 2025, Samsung Electronics entered into advanced investment negotiations with Exo, a U.S. startup developing AI-powered, smartphone-integrated portable ultrasound devices. The move signals Samsung's expansion into mobile diagnostics and healthcare imaging.

✅ In April 2025, Dexcom received FDA clearance for its G7 15-Day Continuous Glucose Monitoring (CGM) system for adults aged 18+, extending sensor wear time to about 151⁄2 days and enabling real-time glucose tracking via smartphones.

✅ In February 2025, the U.S. FDA issued a warning for users of smartphone-connected diabetes devices to verify that smartphone and software settings are correctly configured to avoid missing critical health alerts.

Japan: Recent Smartphone-Enabled Medical Device Developments

✅ In June 2025, MedHub-AI secured PMDA approval in Japan for AutocathFFR®, an AI-driven software that computes Fractional Flow Reserve from standard X-ray coronary angiograms, delivering results in just 37 seconds to support cardiology decisions.

✅ In 2023-2024, Japan's PMDA and MHLW introduced the "DASH for SaMD 2" framework, establishing a two-stage approval process for Software as a Medical Device and setting a six-month target review period for priority submissions.

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Smartphone-Enabled Medical Devices Market refers to healthcare devices that integrate with smartphones to monitor, diagnose, and manage medical conditions in real time. These devices include glucose monitors, ECG monitors, blood pressure monitors, pulse oximeters, and wearable sensors that connect via apps or wireless technologies. The market is driven by rising demand for remote patient monitoring, telehealth adoption, and the growing need for accessible, portable, and cost-effective healthcare solutions.

Recent Mergers and Acquisitions

United States: Notable Recent M&A

✅ In March 2025, Boston Scientific acquired SoniVie Ltd. to expand its interventional portfolio, particularly in renal denervation and related vascular therapies.

✅ In January 2025, Stryker acquired Inari Medical for approximately $4.9 billion, strengthening its position in vascular device technologies including treatments for blood clots and peripheral vascular disease.

✅ In January 2025, Zimmer Biomet completed its acquisition of Paragon 28 for around $1.2 billion, enhancing its foot and ankle surgical technology offerings.

Japan: Notable Recent M&A

✅ In March 2025, KKR and Japan Investment Corp (JIC) agreed to take Topcon, a Japanese medical equipment manufacturer, private in a tender offer valued at USD $2.31 billion.

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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