Software as a Medical Devices Market is Driven by Digital Health During (2024-2031) | Key Players:Arterys Inc., Viz.ai, Inc., VitalConnect., Apple, Inc

Software as a medical devices (SaMD) market is estimated to reach at a CAGR of 69.31% during the forecast period (2024-2031).

Software as a Medical Devices Market is set to expand significantly over the next few years, according to the latest market intelligence report. This comprehensive study analyzes emerging trends, market size, pricing dynamics, and strategic opportunities, empowering B2B marketers, analysts, and industry stakeholders with critical data for informed decision-making.

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Software as a Medical Device (SaMD) is standalone software designed for medical purposes such as diagnosing, monitoring, or treating diseases without being embedded in a physical device. It runs on platforms like smartphones, computers, or cloud systems and is regulated by authorities like the FDA and EU MDR. SaMD plays a vital role in digital healthcare, enabling applications like AI-driven diagnostics, remote monitoring, and clinical decision support.

Market Players in the Software as a Medical Devices market

The prominent players in Software as a Medical Devices market research report are:
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.

The companies are primarily focusing on strategies such as new product launches to penetrate the fastest-growing emerging markets across the world.

Software as a Medical Devices Market Key Development

▶ In 2025, Medtronic acquired a health-tech startup specializing in AI-based SaMD for cardiovascular diagnostics, aiming to expand its digital health portfolio and precision care offerings. Similarly, Siemens Healthineers merged with a European SaMD firm to strengthen its imaging software solutions.

▶ Philips launched a cloud-integrated SaMD platform in Q1 2025 that assists radiologists with real-time diagnostics and decision support using AI. Roche also introduced a diabetes management SaMD that integrates with wearable glucose monitors for automated patient feedback.

▶ Regulatory agencies, including the FDA and EU MDR, introduced updated frameworks in mid-2025 to accelerate approval timelines for AI-powered SaMDs. Additionally, the WHO launched a global collaboration to standardize safety protocols for SaMD across emerging markets.

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Software as a Medical Devices Market Segments

By Device Type: Wearable Device, PCs/Laptop, Smartphone/tablets

By Application: Diagnostic, Clinical Management

By Deployment Method: Cloud-based, On-Premise

The Software as a Medical Devices industry is experiencing rapid growth, driven by advancements in medical technologies, increased demand for innovative therapies, and a rising focus on patient-centered care. As these sectors evolve, the need for comprehensive market analysis becomes crucial to understand trends, regulatory changes, and emerging opportunities.

Research Methodology

Our analytical framework employs cutting-edge statistical modeling and data mining techniques to identify emerging patterns, forecast market trajectories, and decode complex industry dynamics. We enhance our findings through sophisticated market segmentation analysis and Porter's Five Forces evaluation, providing a 360-degree view of the competitive landscape. This multi-layered methodology ensures our delivered insights are not only data-driven and credible but also strategically relevant and immediately actionable for critical business decisions.

Regions Covered:

The global Software as a Medical Devices Market report focuses on six major regions: North America, South America, Europe, Asia Pacific, the Middle East, and Africa.

☞ North America - US, Canada, Mexico

☞ Europe- Germany, Russia, UK, France, Italy, Rest of Europe

☞ Asia Pacific- China, India, Japan, Australia, Rest of Asia Pacific

☞ South America- Brazil, Argentina, Colombia, Rest of South America

☞ Middle East and Africa- Saudi Arabia, UAE, Oman, Bahrain, Qatar, Kuwait, Israel

This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, Market Access, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

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