FDA Output
FDA Output, October 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2026. Updated October 29.
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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: RAPID Feedback
Medtech groups formally respond to CMS’ RAPID proposal for regulatory-reimbursement alignment. Excerpted from Pathways Picks October 14: RAPID Response, Notified Body Needs, CDRH Retirement, and More.