FDA Output
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 17.
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Start-Ups
Luminate Medical Wraps Its Arms around Cancer Care
With a mission of making cancer care more tolerable to patients, Luminate has advanced device products for the prevention of chemotherapy-induced hair loss and peripheral neuropathy. It’s now overhauling the provision of care itself, with a technology-enabled solution for the delivery of oncology therapeutics at home.
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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.