The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

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

Marcel Botha discusses ways the agency can ensure it gets the most accurate results possible from AI.

An FDA official said about 6,000 people are using the tool weekly. AI can “modernize the FDA and radically increase efficiency in the review process,” Makary wrote in JAMA. Makary is trying to cheer ...

Spectral AI, Inc. (NASDAQ:MDAI) is one of the most popular AI penny stocks to buy according to billionaires. On June 30, Spectral AI (NASDAQ:MDAI) submitted a De Novo 510k application to the FDA for ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

All FDA centers are being directed to deploy AI immediately to achieve full integration by the end of June. AI is a transformative technology, but issues have arisen with AI accuracy.

The burden then shifts to hospitals, which puts clinicians in a tough spot, relying on AI that might not generalize, with no ...

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't connected to the Internet or the FDA's internal system, and has problems ...

Key Points. FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

FDA’s AI tool for medical devices struggles with simple tasks. The agency announced Monday that a separate AI tool, called Elsa, had been rolled out to all FDA employees.