But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

Earlier this year, the FDA unveiled Elsa, an artificial intelligence tool that's expected to speed up the process for ...

Respiree announced that it received a second FDA 510(k) clearance for its RS001 cardio-respiratory wearable device.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI-designed therapies and digital twin technology are ...

It marks the second time Tempus AI has received FDA clearance for a cardiovascular product suite.

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk. Medical device cyberattacks are already common. The additional layer of AI ...

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

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 ...

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 ...