The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
The FDA has issued draft guidance to provides recommendations to sponsors and other interested parties on the use of artificial intelligence to ...
The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...
Of the 1,757 total AI use cases reported by federal agencies last year, 227 of them were listed as safety- or ...
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
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