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 to Watch
VahatiCor: On the Trail of Microvascular Disease
Coronary microvascular disease can contribute to major cardiovascular pathology, but there are no approved disease-modifying therapies. On the hunt for a new solution, VahatiCor is pursuing a new device that narrows coronary sinus flow to improve perfusion in the microvascular network.
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Regulatory & Reimbursement
Pathways' Pick of the Week: South Korea Eyes Novel Regulatory Routes for AI
MDFS announces its variation on staged approvals for AI. Excerpted from Pathways Picks September 16: TAVR Coverage, New AI Routes, Harmonization Actions, and More.