Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Key Points Spectral Ai completed its De Novo application submission to the FDA for the DeepView System in June 2025, marking a major regulatory milestone. Revenue for the quarter declined 32.0% year ...

FDA staffers aren't making progress with new agency chatbot, billed as a game-changer for lengthy approval processes. - Thomas Fuller / SOPA Images /LightRocket via Getty Images Yahoo is using AI to ...

A new FDA program will use a two-phase approach to help boost domestic drug manufacturing, while OpenAI is leaning into health care with the launch of GPT-5.

As agentic AI advances, it will impact patient-facing healthcare delivery models, while new questions around the ...

Sonic Incytes Medical Corp, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool ...

On June 2, the FDA dropped the other shoe, saying it had launched a generative AI tool called “Elsa” to help scientific reviewers and investigators work more efficiently.

Following FDA’s first AI-assisted medical product review, the agency has committed to expanding the use of generative AI across all centers by June 30, 2025. Commissioner Makary emphasized the ...