FDA Output
FDA Output, October 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2026. Updated October 13.
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The Brief
Renal Denervation Winds Shift in Recor’s Favor
Recor Medical, an Otsuka subsidiary, is expanding access to its Paradise ultrasound renal denervation technology with the help of national Medicare coverage, professional guidelines, and clinical results supporting renal denervation for the treatment of drug-resistant hypertension.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: PMAs’ Electronic Future
FDA takes a step toward mandatory electronic PMAs. Excerpted from Pathways Picks September 21: PMA eSubmissions, GRAIL Panel, China AI Study Guide, and More.