FDA Output
FDA Output, March 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in March 2026. Updated March 30.
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Start-Ups
WhiteSwell’s Lymph-Targeted ADHF Therapy Aims for System-Wide Improvements
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."
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Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Digital Device Rise
Digital device approvals are way up from last year. Excerpted from Pathways' Picks March 11: CDRH Hiring Push, UK Taps Former FDAer, Global Policy Updates.