US Software as a Medical Device Market to hit US$ 715.00 million by 2033 | Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica, Bigfoot Biomedical

"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." As per DataM intelligence research report

US Software as a Medical Device Market: Recent Industry Developments

✅ In July 2025, FDA granted clearance to Aidoc's AI Triage Platform for detecting pulmonary embolism and intracranial hemorrhage from CT scans.The software integrates with hospital PACS systems to prioritize urgent cases for radiologists.It is now deployed in multiple large U.S. health systems to improve emergency care workflows.

✅ In June 2025, Tempus launched its Tempus OneTM AI-powered clinical decision support SaMD for oncology.The platform analyzes genomic and clinical data to recommend personalized cancer treatment options.Major cancer centers across the U.S. are adopting it to enhance precision oncology programs.

✅ In May 2025, Viz.ai secured $50 million in funding to expand its AI Stroke Detection and Coordination Software.The SaMD automatically alerts stroke teams when large vessel occlusions are detected in imaging scans.It has shown to reduce door-to-treatment times by up to 40% in U.S. hospitals.

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US Software as a Medical Device Market: Drivers

✒ Growing Adoption of Digital Health Solutions - Increasing demand for remote patient monitoring, telemedicine, and AI-driven diagnostics is accelerating the integration of SaMD into healthcare workflows.

✒ Advancements in AI and Machine Learning - The rise of predictive analytics, image recognition, and personalized treatment algorithms is enhancing the capabilities of SaMD, leading to faster and more accurate clinical decisions.

✒ Supportive Regulatory Environment - The U.S. FDA's evolving SaMD-specific guidelines and pre-certification programs are fostering innovation and market entry for software-based medical solutions.

✒ Shift Towards Value-Based Healthcare - Hospitals and providers are increasingly investing in software tools that improve patient outcomes, reduce hospital readmissions, and optimize operational efficiency.

✒ Integration with Wearables and IoT Devices - The growing ecosystem of connected medical devices, from smartwatches to implantable sensors, is driving demand for SaMD platforms that analyze and act on real-time health data.

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Segment Covered in the US Software as a Medical Device Market:

➥ By Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others
➥ By Indication: Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others

Strategic Players Driving the US Software as a Medical Device Market Forward:

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

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Regional Analysis for US Software as a Medical Device Market:

The United States holds a leading share in the global SaMD market, supported by a robust digital health ecosystem, high healthcare IT spending, and a favorable regulatory framework. The country benefits from strong collaboration between technology firms, healthcare providers, and research institutions, enabling rapid commercialization of innovative solutions. Urban healthcare systems show higher adoption due to advanced infrastructure and reimbursement readiness, while rural areas are increasingly tapping into telehealth-enabled SaMD solutions to bridge care gaps. Compared globally, the U.S. is ahead in AI-enabled SaMD adoption, clinical trial activity, and integration with electronic health records (EHRs).

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