Regulatory & Reimbursement
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 5.
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Start-Ups to Watch
Eclipse Medical’s Return to LAAO
After a successful first launch and a brief market hiatus, a Dublin-based start-up prepares to introduce an updated version of its left atrial appendage closure device.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Second-Place De Novo Support
FDA lends a hand to companies pursuing De Novo authorization. Excerpted from Pathways’ Picks October 21: CDRH Hiring, EU Reform Timeline, AI Policy Plans, and More.