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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.
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InvestorsHub on MSNTempus AI shares climb after FDA approval of heart monitoring softwareTempus AI, Inc. (NASDAQ:TEM) saw its stock rise 3% on Wednesday following the announcement that the company obtained 510(k) ...
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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...
On June 2, the FDA dropped the other shoe, saying it had launched a generative AI tool called “Elsa” to help scientific reviewers and investigators work more efficiently.
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, ...
A key takeaway from FDA’s discussion papers and recent activities associated with AI/ML is that the agency recognizes the profound potential benefits to advance drug development, manufacturing ...
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.
In a review of 130 FDA-cleared AI tools, researchers found that the vast majority of them relied on retrospective studies. Most of the developers also didn’t share information on how many sites ...
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