Software as a Medical Devices Market is Boosted by AI Regulatory Support and Remote Monitoring Demand|Key Players: Arterys Inc., VitalConnect., Apple, Inc., iSchemaView, inc.

Software as a medical devices (SaMD) market reached USD 1.85 Billion in 2024 is estimated to reach 6.11 Billion by 2033 at a CAGR of 69.31% during the forecast period (2025-2033).

The latest Software as a medical devices Market Report by DataM Intelligence offers a clear analysis of global trends, market size, key players, and growth drivers. Covering emerging technologies, evolving care models, and regulatory insights, it provides strategic intelligence to help stakeholders navigate the dynamic healthcare landscape through 2025-2033

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Software as a Medical Device (SaMD) includes software intended for medical purposes without being part of a hardware device, such as diagnostic tools, clinical decision support, and digital therapeutics. The market is expanding rapidly with regulatory advancements, increased AI integration, and growing adoption in remote care, chronic disease management, and personalized medicine.

Software as a medical devices Market Competitors Overview:

Arterys Inc., Paragon Biosciences (Qlarity Imaging LLC), Viz.ai, Inc., VitalConnect., Apple, Inc., iSchemaView, inc. (RAPID), IDx Technologies Inc., MaxQ AI, Ltd. Greenfinch Technology, Siemens Healthineers AG, and Koninklijke Philips N.V.

Important Industry Updates of 2024 and 2025:

✅ On January 8, 2025, Warburg Pincus began exploring the sale of Modernizing Medicine, a cloud-based EHR and AI-driven healthcare software provider, with a potential valuation exceeding $5 billion.

✅ On March 15, 2025, Bain Capital finalized its $2.6 billion acquisition of HealthEdge from Blackstone, aiming to integrate generative AI capabilities into the company's healthcare payer software suite.

✅ On June 11, 2025, Becton Dickinson announced the merger of its Biosciences & Diagnostics unit with Waters Corporation in a $17.5 billion deal, marking a strategic shift to prioritize core medtech while expanding software analytics integration.

Software as a medical devices Market Segments Overview:

∎ By Device Type ( Wearable Device, PCs/Laptop, Smartphone/tablets)
∎ By Application ( Diagnostic, Clinical Management)
∎ By Deployment Method ( Cloud-based, On-Premise)

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Methodology and Scope:

This Software as a medical devices Market report is developed using a robust research methodology that combines primary interviews, insights from industry experts, and verified secondary sources such as company filings, trade journals, and trusted databases. It follows a bottom-up and top-down approach to ensure data accuracy through triangulation. The scope of the report covers current market trends, growth potential, and strategic developments across global and regional markets.

Regional Overview for Software as a 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)

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The Report Includes:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the global market.
➡ Go-to-market Strategy.
➡ Neutral perspective on the market performance.
➡ Customized regional/country reports as per request and country level analysis.
➡ Potential & niche segments and regions exhibiting promising growth covered.

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