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 10.
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The Digest
The Digest August 2026
This month, consumer tech giants acquire or partner to put core skill sets to use for medical applications; two private equity deals signal what's hot; and Curium, curiously, creates a radiopharmaceuticals giant.
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Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Floats GenAI Plan
FDA proposes a “competency” framework for regulating generative AI; Excerpted from Pathways Picks August 19: FDA GenAI Plan, Commish Nom, Global Picks, and More.