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

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

Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

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

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

In a breakthrough for cardiovascular medicine, researchers have harnessed artificial intelligence to discover unexpected ...

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

Medical device lobbyists and lawmakers have united in recent months over legislation that would make it easier to bill ...

A new technology that harnesses artificial intelligence (AI) to analyze mammograms and improve the accuracy of predicting a ...

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 ...