FDA Releases Two Discussion Papers on AI and ML
WEBTo address these concerns, the FDA has released a discussion paper, “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.” AI and ML in the ...
FDA Releases Artificial Intelligence/Machine Learning Action Plan
WEBToday, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan...
Artificial Intelligence and Medical Products | FDA
WEBLearn more about how the FDA is shaping the future of health care through the responsible and innovative integration of AI.
SCOPE: FDA facilitates AI and ML use for clinical trials and drug ...
WEBFeb 13, 2024 · The US Food and Drug Administration (FDA) is focusing on how artificial intelligence (AI) can be used to support clinical trials but says it will take time to get there, as per a regulatory official speaking at the SCOPE Summit.
FDA official sets out approach to AI in medical devices
WEBJun 18, 2024 · The FDA has clarified its thinking through guidance documents and standards as it regulates a growing number of medical devices with an AI or machine learning component.
5 takeaways from the FDA’s list of AI-enabled medical devices
WEBNov 7, 2022 · MedTech Dive analyzed FDA data on all of the AI- and machine-learning-enabled devices the agency has authorized to date. Here are five takeaways on the rise of these devices. 1. The number of AI-enabled medical devices has surged in …
FDA publishes list of AI-enabled medical devices
WEBOn October 19th, the FDA published its 2023 list of authorized AI-enabled medical devices. This year 171 additional medical devices were added to the list; a 33% increase in one year.
InnovationRx: FDA Commissioner Talks Healthcare AI - Forbes
WEB1 day ago · The FDA has authorized 950 AI and machine-learning-enabled medical devices as of August 7 with the majority of them being radiology software, but the next generation of software medical devices is ...
FDA drafts guidance to ease path to updates for AI-enabled devices
WEBMar 30, 2023 · Medtech companies will be able to more easily update devices with an artificial intelligence or machine learning component under a new regulatory framework being developed by the Food and Drug Administration.
FDA’s Action Plan for Artificial Intelligence: Highlights and Insights ...
WEBJan 12, 2021 · The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory …
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