With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...

Dubbed Elsa, the tool was expected to roll out at the end of June. The FDA says it marks the dawn of a new era.

The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, ...

FDA approves CLAIRITY BREAST, a new AI breast cancer prediction tool that helps doctors assess five-year risk from routine ...

JBA AI has been officially recognized by the United States Food and Drug Administration (FDA) as a Software as a Medical ...

A former FDA reviewer offers advice to help innovative medtech avoid new and more dangerous pitfalls as experts leave the ...

The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...

There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...

The Food and Drug Administration has introduced a new AI tool that could expedite the review and approval process for medical ...

AI-driven Clairity Breast platform, now FDA-approved, predicts five-year breast cancer risk from mammograms, enhancing early ...