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In this week’s Pathways Picks: EU lawmakers seek to clarify MDR/IVDR, not AI Act, as controlling authority over AI-enabled devices; MDR certifications grow; FDA issues guide on patient preference information; active South Korea agency approves first generative AI device and expands real-world evidence use; and more updates from Europe, the US, and South Africa.
While diuretics act directly on the fluid-overloaded vascular compartment, WhiteSwell believes that during episodes of ADHF, to effectively restore balance, interstitial fluid must be moved out of the congested tissues. The start-up plans to accomplish this with a device called the eLym System, now being studied in a multicenter, prospective single-arm study called DELTA-HF. 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.