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

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

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

The integration of artificial intelligence (AI) in the cardiovascular space, particularly in electrocardiography (ECG), is reshaping clinical workflows, enabling earlier disease detection and opening ...

In May, AI researchers claimed there was “definitive” proof that Health Secretary Robert F. Kennedy Jr. and his team used the ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

FDA’s Broader AI Goals. The launch of Elsa is part of a broader “AI-forward” strategy. In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

Joseph Jeanmarie dealt with the pain, mostly working at a pain level of eight out of 10. Now, new technology his helping him ...

The FDA has cleared an overwhelming majority of AI devices through its 510(k) pathway, which is less rigorous, faster and cheaper than the agency’s other market authorization options.

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, potentially speeding up responses to food safety issues like recalls.