STAT Health Tech: After Elsa, FDA rolls out ‘agentic AI’ for staff

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

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The FDA announced it will continue its speedy push into the AI unknown with new “agentic AI capabilities” to support a range of regulatory work including pre-market reviews, review validation, post-market surveillance, inspections, and compliance. An agency spokesman told me that all regulatory decisions will ultimately be in the hands of staff. 

You may remember that the FDA, earlier this year, launched Elsa, an LLM-based tool to support agency staff. Early users reported the errors and fabulations that come along with LLM-based tech. FDA now claims over 70% of staff have used the product.