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 30.
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Start-Ups to Watch
Vexev’s Robotic Solution for Renal Care Accessibility
A Sydney-based start-up makes vascular modeling quick and simple for dialysis patients amid a shortage of qualified specialists.
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Business Strategies
Making MAC a Priority
Mitral annular calcification has emerged as a priority in cardiology, as evidence increasingly links the condition to heart failure risk and procedural complications during mitral valve interventions. Bunkerhill Health’s solution enables early, consistent, and scalable identification of the condition. Excerpted from our recent feature article, Attacking MAC.