FDA Output
FDA Output, November 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in November 2026. Updated November 9.
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The Digest
The Digest: November 2026
In this month's news, FDA issues 510(k) clearance for a series of AI imaging technologies, EQT buys Qiagen for upwards of $12 billion, Labcorp's acquisition spree, and more.
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Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Plans First GenAI Guidance
FDA drafts mental health generative AI guidance. Excerpted from Pathways Picks October 7: AI Plans in the UK and US, Europe’s First JCA Devices, and More.