FDA Output
FDA Output, March 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in March 2026. Updated March 9.
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Video Interviews
Despite Headwinds, Why Medtech Seems Headed for 2026 Reset
Years of macro and policy headwinds have dragged down medtech valuations, but the industry may be entering a period where fundamentals and innovation reignite investor sentiment. Strategics and private equity alike are repositioning their portfolios around new, higher‑growth opportunities. The AAOS meeting in New Orleans will offer a look at how aggressively the sector is preparing for its next growth leg. Watch our interview with Ryan Zimmerman of BTIG and Masha Dumanis of Kx Advisors.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Great Britain Won’t Quit the CE Mark
A MHRA proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain. Excerpted from Pathways’ Picks February 18: Britain Gives in to the CE Mark, CMS ACCESS Updates, South Korea Wellness Policy.