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, ...

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

The U.S. Food and Drug Administration has granted de novo authorization to CLAIRITY BREAST, a first-in-class, image-based ...

The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving ...

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

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

The FDA rolled out its agency-wide AI tool weeks ahead of schedule, on Monday offering a look at the technology and how it ...

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

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

SMARTER SCREENINGS: The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk. 'WE WILL FIGHT': OpenAI CEO Sam Altman said ...