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 5.
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Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in February 2026. Updated February 5.
A Sydney-based start-up makes vascular modeling quick and simple for dialysis patients amid a shortage of qualified specialists.
Pulsed field ablation is set to supplant radiofrequency and cryoablation as the preferred catheter-based approach to stopping arrhythmias. Because it is safer and faster than older technologies, it is helping electrophysiologists treat more patients and accelerate the overall growth of the cardiac ablation business. Excerpted from our recent feature, "PFA Is Ready to Electrify the Electrophysiology Market."