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 16.
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Business Strategies
Olympus’ EAGLE Flies to the Cloud: AI-Powered Colonoscopy Takes Off
The EAGLE trial showed Olympus’ cloud-based CADDIE AI outperforms standard colonoscopy in real-time lesion detection—marking the start of Olympus’ broader push to use AI for improved detection, therapy, and workflow across its clinical portfolio.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: MDUFA VI Talks: Sticking Points and Progress
MDUFA VI talks between FDA and industry advance, with some snags. Excerpted from Pathways’ Picks Febraury 11: User Fee Sticking Points, AdvaMed Hire, China Clinical Trial Policy.