The Rise of Software as a Medical Device: What It Means for Healthcare Innovators

Rise of Software as a Medical Device In an era where digital health is reshaping the future of medicine, Software as a Medical Device (SaMD) is at the forefront of innovation. From AI-driven diagnostics to personalized treatment algorithms, SaMD is not just transforming healthcare delivery — it's redefining the very essence of medical devices. 🚀 What Is Software as a Medical Device (SaMD)? According to the International Medical Device Regulators Forum (IMDRF), SaMD refers to “software intended to be used for medical purposes without being part of a hardware medical device.” In simpler terms, it's standalone software that can diagnose, monitor, treat, or prevent disease — without needing to be embedded in a physical device like a scanner or wearable. 🔍 Examples: AI-powered apps that analyze chest X-rays for pneumonia Algorithms for insulin dose calculation in diabetes patients Remote cardiac monitoring tools using smartphone ECGs Mental health apps off...