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US Software as a Medical Device Market to hit US$ 715.00 million by 2033 | Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica, Bigfoot Biomedical
US Software as a Medical Device Market
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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The US Software as a Medical Device Market report by DataM Intelligence provides comprehensive insights and analysis on key market trends, growth opportunities, and emerging challenges. With a commitment to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. By combining qualitative and quantitative research methodologies, the firm delivers in-depth reports that help clients navigate complex market dynamics, drive strategic growth, and seize new opportunities in an ever-evolving global landscape.
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➠ Technology & Innovation: Tracks clinical trials and upcoming pharmaceutical advancements to stay ahead in product development.
➠ Market Positioning & Competitive Strategy: Analyzes product performance, market share, and competitor tactics for strategic decision-making.
➠ Real-World Evidence & Physician Insights: Incorporates patient data and physician behavior to align products with actual healthcare needs.
➠ Pricing & Market Access: Reviews reimbursement trends and access models to optimize product pricing and launch strategies.
➠ Regulatory & Industry Shifts: Covers policy changes, health system dynamics, and technology trends impacting market opportunities.
➠ Regional Growth & Expansion: Identifies high-growth markets and investment opportunities for geographic expansion.
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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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