Software as a Medical Device (SaMD)

Sep 16, 2026

Healthcare used to be defined by devices you could hold: a stethoscope, an MRI scanner, an insulin pump. Increasingly, it's defined by devices you can't hold at all. An algorithm that flags a suspicious mole from a smartphone photo. A program that reads a chest CT and prioritizes the most urgent case in a radiologi...

May 07, 2025

Artificial Intelligence (AI) and Machine Learning (ML) are reshaping the world of Software as a Medical Device (SaMD), bringing a new level of intelligence and efficiency to healthcare. SaMD refers to software designed for medical purposes that doesn’t rely on physical hardware. When integrated with AI/ML, these so...