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
In Breast Cancer, Innovators Are Coming Up the Curve
Breast cancer is highly manageable when caught early, yet clinicians still face challenges: patient stratification after screening isn’t precise enough, and surgical outcomes could be improved. We spoke with Clairity, Cairn Surgical, and Resilient Medical—innovators working to raise the standard of care for this disease that predominantly affects women.
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Pathways’ Pick of the Week
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.