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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Start-Ups
Minovia Therapeutics and the Mighty Mitochondria
An Israel-based start-up is taking on a cellular-level challenge that is somehow both elusive and ubiquitous at the same time.
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Business Strategies
Label Change for Ruptured AAAs
FDA approval of a labeling change that will allow Medtronic and Gore to help physicians learn to use stent grafts to treat ruptured abdominal aortic aneurysms. Excerpted from our recent feature article “Medtronic and Gore Break Through EVAR-Labeling Logjam.”