US Software as a Medical Device (SaMD) Market to Surpass US$ 715 Million by 2033, Driven by AI Diagnostics and Evolving Regulatory Pathways | Top Companies are Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica.

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.

According to DataM Intelligence has published a new research report on "US Software as a Medical Device Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

Software as a Medical Device (SaMD) refers to software intended to perform medical functions without being part of a hardware medical device such as diagnosing, monitoring, or treating health conditions. It includes AI/ML diagnostic tools, clinical decision support systems, remote monitoring applications, and digital biomarkers. SaMD must demonstrate safety, effectiveness, clinical validity, and robust cybersecurity, and in the United States it is regulated by the Food and Drug Administration (FDA) under medical device frameworks.

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➣ Recent Developments:

Regulatory & Policy Updates
✅ In July 2025, the FDA finalized updated guidance on AI/ML-based SaMD, clarifying expectations around continuous learning algorithms, real-world performance monitoring, and transparency requirements.
✅ In June 2025, the FDA expanded its Digital Health Software Precertification (Pre-Cert) Pilot Program, streamlining SaMD review for trusted developers while maintaining safety and performance standards.
✅ In May 2025, the agency issued new recommendations on cybersecurity and post-market vulnerability disclosures for connected SaMDs, emphasizing secure coding and real-time threat reporting.

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SaMD Adoption & Innovation Trends
AI-Driven Diagnostics & Decision Support
• Increased deployment of AI algorithms for radiology, cardiology, and oncology, enabling early disease detection with interpretive insights.
• Growth in clinical decision support tools that help clinicians personalize treatment plans and reduce diagnostic variability.

Remote Monitoring & Telehealth Integration
• SaMD solutions tied to wearables and mobile platforms now support real-time monitoring of heart rhythms, glucose, respiratory patterns, and neurocognitive metrics.
• Telehealth platforms are embedding FDA-cleared SaMD modules to enhance virtual consultations with actionable data.

Regulatory Clarity & Innovation Pathways
• SaMD developers are increasingly using FDA's Breakthrough Devices Program for high-impact tools addressing unmet clinical needs.
• Sponsors are submitting Real-World Evidence (RWE) to support pre-market approval and label expansions for evolving indications.

Data Privacy & Security
• Stronger emphasis on HIPAA-aligned encryption, secure update mechanisms, and incident reporting to ensure data integrity and patient trust.
• Developers are adopting continuous validation frameworks to detect performance drift in adaptive AI SaMDs.

➣ Top Industry Players:

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

➣ Market Segments:

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

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

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Regional Break out:

☞ 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

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