Browsing: FDA

The Food and Drug Administration lacks adequate staffing to oversee medical device recalls, according to a report released Friday by…

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What You Should Know:  – Ceribell, Inc. has secured FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring…

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Dive Brief: The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new…

What You Should Know:  – PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI…

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Share on PinterestA nationwide recall of shredded cheese products that may contain metal fragments raises concern over the possible risks…

What You Should Know:  – The U.S. Department of Health and Human Services (HHS) has released its comprehensive AI Strategy,…