Exclusive: FDA to roll out AI tool agency-wide earlier than expected

Weeks ahead of schedule, Elsa the AI tool is a "language learning model" and "chat tool" intended to summarize document

Log In    Subscribe Exclusive   FDA plans to begin rolling out AI tool agency-wide on Tuesday By Brittany Trang Sarah Silbiger/Getty Images The FDA plans to roll out its agency-wide AI tool on Tuesday, weeks ahead of schedule, according to a press release obtained by STAT.   Commissioner Marty Makary has hailed the potential of the AI at the FDA, saying it could save employees time and ultimately speed up regulatory reviews. At the same time, FDA employees characterized the launch of the AI, called Elsa, as "rushed" and expressed concern the agency is both over-inflating its capabilities and failing to set guardrails. READ MORE Sign up for STAT's AI Prognosis newsletter A hitchhiker's guide to the health care AI galaxy. Learn more. In Case You Missed It The shrewd startup founder who led DOGE's cost-cutting at HHS By Tara Bannow Doctors didn't catch AI's mistakes. What does that mean for human-in-the-loop? By Brittany Trang mRNA, once lauded as a scientific marvel, is now a government target By Lizzy Lawrence and Isabella Cueto FDA commissioner evades questions on Covid shot, calls CDC panel a 'kangaroo court' By Lizzy Lawrence Don't miss out on another STAT Investigation Unlock the world of health and medicine with a subscription to STAT+ Learn more STAT, 1 Exchange Place, Boston, MA ©2025, All Rights Reserved. I no longer wish to receive STAT emails Update Newsletter Preferences • Contact Us • Advertise with Us