Regulatory & Reimbursement
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 11.
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Start-Ups
CpG Diagnostics: De-risking Ovarian Cancer Treatment
A Southern California start-up uses a blood test-based method to address glaring gaps in ovarian cancer diagnosis.
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Regulatory & Reimbursement
Pathways' Pick of the Week: MDR Numbers Grow
The number of MDR submissions and certificates is trending up. Excerpted from Pathways’ Picks April 1: AI Act Deemphasized, MDR Numbers, Generative AI Approval, and More.