The approval of ArteraAI Prostate by the FDA as a software as a medical device (SaMD) means it can now be used at the point ...

The FDA’s De Novo authorization for the tool establishes a new product code category for future AI-powered digital pathology risk-stratification tools.

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

The US Food and Drug Administration (FDA) has granted de novo authorisation to Artera’s ArteraAI Prostate software. This ...

Recent reports highlight uncertainty about pharmaceutical tariffs, an error-prone AI tool in use at the FDA, and research funding in jeopardy.

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 ...

Artificial intelligence is transforming healthcare — we must align government policies to support this progress. It will save ...

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 ...

Extensively studied over decades, fluoride has been scientifically validated for its effectiveness in reducing dental ...

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.