U.S. Software as a Medical Device Market Size to Reach US$ 715.00 million by 2033 - Exclusive Report by DataM Intelligence

The U.S. Software as a Medical Device (SaMD) market was valued at US$ 205.12 million in 2024 and is projected to reach US$ 715.00 million by 2033, expanding at a CAGR of 13.5% during the forecast period 2025-2033.

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Mergers & Acquisitions (M&A):
✅ Clearlake Capital & Modernizing Medicine: Clearlake Capital acquired a majority stake in healthcare software company Modernizing Medicine (ModMed) for $5.3 billion, marking it as the largest healthcare sector leveraged buyout in 2025. ModMed offers electronic health records systems, which are utilized by over 160,000 specialty physicians and surgeons in the U.S.

✅ Bain Capital & HealthEdge: Bain Capital reached a $2.6 billion deal to acquire U.S. healtcare software firm HealthEdge from Blackstone. HealthEdge provides advanced software solutions to modernize systems for 115 U.S. health insurers covering over 110 million lives. The acquisition aims to integrate generative AI into healthcare.

✅ Waystar & Iodine Software: Waystar announced its acquisition of Iodine Software for $1.25 billion. The deal brings under Waystar's umbrella Iodine's AI-driven documentation and reimbursement tools used by hospitals and healthcare providers.

✅ Siemens & Dotmatics: Siemens AG announced the acquisition of U.S.-based R&D scientific software company Dotmatics for $5.1 billion. This move aims to bolster Siemens' Life Sciences portfolio and expand its presence in the software market associated with industrial and life sciences sectors.

Product Launches & Regulatory Updates
✅ FDA's Regulatory Accelerator: On July 24, 2025, the FDA launched the Regulatory Accelerator to support digital health innovators in navigating medical device software regulations. It provides tools and guidance to improve submission quality and speed up market access.

✅ FDA's Draft Guidance on AI-Enabled Devices: On January 6, 2025, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. This draft guidance proposes both lifecycle considerations and specific recommendations to support marketing submissions for AI-enabled medical devices.

✅ IMDRF's Final Document on SaMD: The International Medical Device Regulators Forum (IMDRF) released the final document, Characterization Considerations for Medical Device Software and Software-Specific Risk, in January 2025. This guidance provides a framework for software development and risk management in medical devices.

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Market Segments:
• By Application (Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others)
• By Indication (Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others)

Market Drivers:
➠ Regulatory Support and Digital Health Initiatives
The US Food and Drug Administration (FDA) has established clear guidelines for SaMD, which provides a structured pathway for software developers to bring medical-grade applications to market. Federal initiatives promoting digital health adoption and reimbursement for software-driven healthcare services are key growth drivers.

➠ Rising Prevalence of Chronic Diseases
Increasing incidences of chronic conditions such as diabetes, cardiovascular diseases, and mental health disorders drive demand for software solutions that facilitate continuous monitoring, early diagnosis, and personalized treatment plans. SaMD platforms enable real-time health tracking, predictive analytics, and remote interventions, significantly improving disease management.

➠ Technological Advancements
Innovations in artificial intelligence (AI), machine learning (ML), and cloud computing are enhancing the capabilities of SaMD. Advanced algorithms enable predictive diagnostics, automated clinical decision support, and personalized therapy recommendations, making software solutions more reliable, efficient, and user-friendly.

➠ Healthcare Cost Reduction and Efficiency
Hospitals and clinics are increasingly adopting SaMD to streamline operations, reduce medical errors, and lower overall healthcare costs. Software solutions that automate routine tasks, monitor patient vitals remotely, and support telemedicine consultations are contributing to operational efficiency and better resource allocation.

➠ Growing Consumer Awareness and Smartphone Penetration
Increasing smartphone adoption and patient awareness of digital health tools are encouraging the use of mobile and cloud-based medical software. Patients are now more proactive in managing their health through apps that offer diagnostic insights, medication reminders, and wellness tracking.

➠ Strategic Collaborations and Investments
Partnerships between healthcare providers, tech companies, and academic institutions are accelerating the development and deployment of SaMD. Investments in R&D and pilot programs help expand the functionality, reliability, and reach of software-based medical solutions.

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Market Key Players:
Key players are Viz.ai, Inc., Medtronic Plc, AliveCor, Empatica, Bigfoot Biomedical, Digital Diagnostics Inc., Imagen and Orthogonal.

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This release was published on openPR.