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China builds frameworks for brain-computer interface implantables, generative AI gets FDA and MHRA attention, and three more key medtech policy focus areas in July and August.
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.