Regulatory & Reimbursement
FDA Output, February 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in February 2026. Updated February 10.
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Start-Ups
Neurescue Takes Back Control During Cardiac Arrest
A Danish start-up’s foolproof solution for non-shockable cardiac arrest takes the guesswork out of an established transvascular technique.
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Regulatory & Reimbursement
Pathways' Pick of the Week: CDRH Recommits to Harmonization
FDA’s device center touts its accomplishments in advancing global harmonization in FY 2025. Exerpted from Pathways’ Picks February 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.