Regulatory & Reimbursement
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 21.
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The Brief
As Dollars Chase AI Dream, Investors Stay Grounded
Despite geopolitical challenges and fierce competition for capital, the medtech investment market has maintained the momentum from 2025 through 2026, according to PwC’s latest medtech deals outlook.
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Pathways’ Pick of the Week
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.