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 9.
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Business Strategies
With Digital Strategy, Vantive Breaks Down Barriers in Kidney Care
Vantive—the kidney-care business that separated from Baxter—is pursuing a digital strategy designed to expand patient access and improve outcomes for dialysis and critical care patients.
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Regulatory & Reimbursement
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.