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In this week’s Pathways Picks: FDA finalizes plan to downclassify AI-based skin cancer detections despite cautions from its advisory panel; the EU expands “well-established technologies” list subject to simplified rules; Chile builds out its regulatory framework; AI and digital health news; and more to watch from China, Canada, and Europe.
Addressing heart failure, Levron Cardiovascular synchronizes the body's "respiratory" pump with the heart beat, to shift fluid out of the lungs and boost outflow from the left ventricle. In essence, the concept turns a physiological interaction that normally exists in the body into a therapeutic advantage. A companion article to "Innovating Heart Failure: Start-Ups Harness Natural Pathways."
FDA finalizes weight-loss tech guide and plans new adverse event database. Excerpted from Pathways’ Picks March 18: MDR Discussions, EtO Revisions, and More Medtech Policy Updates.