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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Start-Ups to Watch
Apreo Health: Transforming the Architecture of Emphysema Treatment
One of The Foundry’s latest alumni offers a new twist on releasing trapped air for emphysema patients.
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Pathways’ Pick of the Week
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.