FDA

For sixty years, getting a drug approved in America has followed the same grinding playbook: run a trial, collect data, package millions of pages of submissions, send it to the FDA, and wait. The average journey from Phase 1 to market takes 10 to 12 years. Nearly half of that, according to FDA Commissioner Marty Makary, is “dead time” — paperwork, administrative lag, and data sitting in limbo. On Tuesday, the FDA said it’s done with dead time. ...

The federal government is running a live experiment on 30 million Americans. An AI program called WISeR is delaying and denying medical care for seniors. The nation’s top health official says AI could make the FDA “irrelevant.” And somehow, nobody in charge sees the contradiction. The Quiet Launch That’s Ruining Lives In January 2026, CMS launched the Wasteful and Inappropriate Service Reduction Model — WISeR — introducing AI-powered prior authorization to traditional Medicare for the first time at scale. ...

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. ...