FDA Output
FDA Output, January 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in January 2026. Updated January 31.
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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: ARPA-H Seeks AI Cardiologist
Agentic AI plans solicited to fill a cardiologist gap. Excerpted from Pathways’ Picks January 21: AI Cardiologist, Record-Setting FDA Approvals, EU Inspections Effort.