FDA Output
FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 30.
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Start-Ups
GI Start-Ups Replace Gut Instincts With Precision Data
We profile three MedTech Innovator accelerator companies using implanted and other devices to gather information once accessible by endoscopy only: Cyted Health, Gravitas Medical, and Plio Surgical.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Recruiting for AdComms
FDA seeks more advisory panelists. Excerpted from Pathways Picks September 30: Robot Evolution, Recruiting FDA Panelists, Global Medtech, and More.