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

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

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.

The wearable, noninvasive CardioTag is designed to capture electrocardiogram, photoplethysmogram, and seismocardiogram signals, as well as heart rate and pulse rate.

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

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

Medical AI company Cardiosense has claimed an FDA clearance for its CardioTag device, a wearable sensor that provides a ...

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

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

Transparency of evidence supporting Food and Drug Administration (FDA) authorization of artificial intelligence (AI)- and machine ...

Cardiosense announced today that it received FDA 510 (k) clearance for its CardioTag wearable sensor device.