The FDA Just Gave Generative AI Its First Shot at Clinical Medicine
The FDA has cleared over 1,357 AI-powered medical devices. Every single one of them used old-school AI — pattern recognition, image classification, signal analysis. Not one ran on a large language model. That just changed. RecovryAI, a San Francisco startup fresh out of stealth, announced that the FDA granted Breakthrough Device Designation to its generative AI chatbot for post-surgical recovery. It’s the first time the agency has given this designation to anything powered by an LLM — and the implications go way beyond one startup’s product. ...