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.

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

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

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 ...

The FDA’s AI program needs to have guardrails in place to ensure it’s working properly. No matter what AI is used for at the FDA, processes must be in place to ensure fairness and accuracy ...

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

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 ...

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.