- Software as a Medical Device (SaMD), which refers to software intended for medical purposes without being part of a hardware medical device, is becoming increasingly essential in modern healthcare systems due to its capabilities in diagnostics, monitoring, and disease management across both clinical and remote settings. These solutions offer enhanced accessibility, real-time insights, and integration with digital health ecosystems
- The surging demand for SaMD is primarily driven by the global rise in chronic diseases, the proliferation of connected health platforms, favorable regulatory pathways, and the increasing need for patient-centric care solutions. Advancements in AI, cloud computing, and mobile health technologies are further accelerating adoption across healthcare providers and patients
- North America dominated the software as a medical device (SaMD) market with the largest revenue share of 44.8% in 2024, attributed to early digital health adoption, supportive regulatory frameworks from the FDA, and robust investment in health tech startups. The U.S. leads the regional market, driven by the widespread integration of AI-powered clinical decision support systems, remote patient monitoring tools, and diagnostic app
- Asia-Pacific is projected to be the fastest growing region in the software as a medical device (SaMD) market, registering a CAGR of 21.6% from 2025 to 2032, due to increasing smartphone penetration, government-led digital health initiatives, growing telehealth adoption, and rising healthcare awareness in countries such as China, India, and Japan
- The cloud-based segment dominated the software as a medical device (SaMD) market with the largest revenue share of 65.4% in 2024, driven by the increasing adoption of scalable, interoperable digital healthcare platforms and growing demand for remote patient care. Cloud-based SaMD offers real-time updates, global accessibility, and integration with telemedicine—making it the most preferred deployment model among healthcare providers
