U.S. Software as a Medical Device Market 2025 | Growth Drivers, Key Developments, Market Growth, Future Insights, Investment

US Software as a Medical Device Market reached US$ 205.12 million in 2024 and is expected to reach US$ 715.00 million by 2033, growing at a CAGR of 13.5% during the forecast period 2025-2033.

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Key Development:

United States: Recent Industry Developments

✅ November 2025: The FDA expanded guidance on AI/ML-based SaMD to accelerate approvals while ensuring patient safety and transparency.

✅ October 2025: Major health tech firms launched cloud-based SaMD platforms for remote diagnostics and clinical decision support.

✅ September 2025: U.S. hospitals increased adoption of SaMD solutions for radiology, cardiology, and chronic disease management.

Japan: Recent Industry Developments

✅ November 2025: Japan's PMDA streamlined regulatory pathways for AI-driven SaMD applications in diagnostic imaging.

✅ October 2025: Japanese startups introduced SaMD solutions focused on early disease detection and personalized treatment planning.

✅ September 2025: Strategic collaborations between pharmaceutical companies and software developers accelerated SaMD commercialization.

Key Players:

Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica, Bigfoot Biomedical, Digital Diagnostics Inc., Imagen and Orthogonal

Growth Forecast Projected:

The U.S Software as a Medical Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, 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 U.S Software as a 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 Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others

By Indication: Indication, Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others

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 U.S Software as a 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 U.S Software as a 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's

Q1: What is the current size of the U.S Software as a Medical Devices Market?

A: In 2024, the U.S Software as a Medical Devices Market was valued at US$205.12 million , reflecting its strong industry presence.

Q2: How large is the U.S Software as a Medical Devices Market expected to be by 2033?

A: By 2033, industry forecasts suggest the U.S Software as a Medical Devices Market will grow to around US$ 715.00 million, demonstrating significant expansion.

Q3: What is the growth rate of the U.S Software as a Medical Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 13.5% during the forecast period from 2025 to 2033.

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