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 31.
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Investors & Dealmaking
The Digest October 2026
In this month's news, 510(k)s for several AI image analysis tools, Steris buys Xodus Medical for $2.1 billion, developments in the Delphi and READI-Home programs for patient-used products, and more.
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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.