U.S Software as a Medical Device (SaMD) Market Growth & Trends 2025

The 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.

U.S Software As A Medical Devices Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving market.

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U.S. Software as a Medical Device (SaMD) refers to software applications that are intended to be used for medical purposes but do not require hardware to achieve their intended medical function. These software solutions are regulated by the U.S. Food and Drug Administration (FDA) if they meet certain criteria, such as diagnosing, monitoring, or treating diseases or conditions. SaMD can include a wide range of applications, including mobile apps, software used for data analysis, clinical decision support tools, and AI-based solutions, all of which are designed to support healthcare professionals or patients in managing medical conditions.

List of the Key Players in the U.S Software As A Medical Devices Market:
Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica, Bigfoot Biomedical, Digital Diagnostics Inc., Imagen and Orthogonal among others.

Industry Development:

In January 2025, Caranx Medical, a medical device company, submitted the world's first AI-powered software for real-time intra-operative guidance during Transcatheter Aortic Valve Implantation (TAVI), a life-saving procedure, to the FDA.

In January 2024, Siemens Healthineers received FDA clearance for Syngo Virtual Cockpit, a secure communication platform enabling real-time image visualization and collaboration among healthcare professionals across multiple locations. This marks the first multi-vendor remote scanning software approved as a medical product.

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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Segment Covered in the U.S Software As A Medical Devices Market:

By Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others

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

Benefits of the Report:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the market.

➡ Top-down and bottom-up approach for regional analysis

➡ Porter's five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players.

➡ By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Market

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People Also Ask:

➠ What is the sales, production, consumption, import, and export value of the U.S Software As A Medical Devices market?

➠ Who are the leading manufacturers in the U.S Software As A Medical Devices industry? What is their operational status in terms of capacity, production, sales, pricing, costs, gross margin, and revenue?

➠ What opportunities and challenges do vendors in the U.S Software As A Medical Devices industry face?

➠ Which applications, end-users, or product types are expected to see growth? What is the market share for each type and application?

➠ What are the key factors and limitations affecting the growth of the U.S Software As A Medical Devices market?

➠ What are the various sales, marketing, and distribution channels in the industry?

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