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
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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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.