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 31.
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Business Strategies
Conformal Medical Joins W.L. Gore Amid LAAO Trials
Multi-industry conglomerate W.L. Gore expands its cardiovascular portfolio into the fast-growing LAAO market with the acquisition of atraumatic occlusion device maker Conformal Medical.
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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.