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A graphical look at some of the key changes to expect in industry fees and FDA performance commitments based on a draft deal to reauthorize the medical device user fee program (MDUFA VI).
In the ALLEVIATE-HF clinical trial, continuous monitoring provided by Medtronic’s insertable cardiac monitor revealed a substantial burden of previously unsuspected arrhythmias in patients with both HFrEF and HFpEF—many of whom would not ordinarily qualify for an implantable cardiac device.
FDA proposes a “competency” framework for regulating generative AI; Excerpted from Pathways Picks August 19: FDA GenAI Plan, Commish Nom, Global Picks, and More.