The U.S. Food and Drug Administration authorized Vitestro's Aletta, the first autonomous blood-draw device for use in the United States, on 19 August, following European regulators' approval two years…
An analysis of all 1,483 AI/ML-flagged records in the Innolitics FDA Device Explorer found 88 AI software-as-a-medical-device clearances that cite a predicate which is not SaMD, and 50 of those are ca…
Abbott launched Libre Assist, an AI-powered tool using image recognition to predict how meals affect glucose levels, at CES on January 5, 2026. The feature extends the FreeStyle Libre continuous gluco…
Nvidia has released an open-source Medical Physics Simulation framework that trains surgical robots in under two minutes, cutting training time from over five hours, by running 8,192 parallel environm…
A veteran engineer with 25 years of platform-building experience argues that horizontal platform architectures are fundamentally wrong for the age of AI agents. Citing McKinsey data showing only 6% of…
A Reuters investigation found that AI-enabled medical devices have caused numerous patient injuries, including strokes, due to malfunctions and misleading guidance. The FDA's adverse event reports for…