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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PFA Is Ready to Electrify the Electrophysiology Market
All the major electrophysiology competitors are developing pulsed field ablation technologies to make treatment of cardiac arrhythmia safer and efficient. PFA is rapidly growing the overall electrophysiology market and every company developing a PFA system insists theirs offers unique advantages.
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ICYMI
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.