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The EU Parliament and Council are just starting work on the European Commission’s proposals to comprehensively reform the MDR and IVDR now that translated texts are ready. Leaders from both bodies say they know quick work is needed, but warn the process is unpredictable.
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."
Rick Abramson picked to lead FDA’s Digital Health Center of Excellence. Excerpted from Pathways’ Picks Febraury 25: Tariff Topsy-Turvy, CPT Panel Decisions, Reliance in South Africa.