Browsing: FDA

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Dive Brief: Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose…

Dive Brief: Beta Bionics has received a warning letter from the Food and Drug Administration following an inspection last year,…

Dive Brief: Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said…

Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The…

What You Should Know – AliveCor, the global leader in AI-powered cardiology, has received U.S. FDA clearance for the next…

Dive Brief: Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect…

Welldoc Builds on its Foundation of 11 Prior FDA 510(k) Clearances with a Generative AI Model Submission COLUMBIA, Md.–(BUSINESS WIRE)–Welldoc®,…

What You Should Know – AccurKardia has announced its second FDA 510(k) clearance for the AccurECG™ Analysis System (v2.0). This…

The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of…