Software as a Medical Device (SaMD) refers to software intended for medical purposes without being part of a hardware medical device. This includes applications that help in the diagnosis, treatment, or monitoring of a disease or condition.
Unlike traditional medical devices, SaMD can run on general-purpose hardware such as smartphones, tablets, and desktop computers. The evolution of technology has allowed SaMD to play a pivotal role in modern healthcare through innovations in artificial intelligence, machine learning, and data analytics.
Software as a Medical Device (SaMD) is revolutionizing healthcare by providing flexible, innovative solutions that improve patient outcomes and streamline healthcare processes. It expands access to diagnostics and treatment, especially for communities in rural or underserved areas. SaMD enhances precision and reduces errors by allowing healthcare professionals to make data-driven decisions. By enabling real-time monitoring and feedback, SaMD enables proactive management of chronic diseases and conditions. Additionally, regulatory oversight from bodies such as the FDA ensures that SaMD meets safety and effectiveness standards, further boosting its credibility and integration into healthcare systems.