nsPFA Cardiac Surgical System

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Pulse Biosciences Gets FDA IDE Nod for Atrial Fibrillation Study
ZACKS· 2025-09-12 01:26
Key Takeaways Pulse Biosciences secured FDA IDE clearance to start its NANOCLAMP AF atrial fibrillation study.The trial will test its nsPFA Cardiac Surgical System in up to 136 patients at 20 global sites.Early EU data show rapid, consistent ablation, with FDA Breakthrough Device status supporting progress.Pulse Biosciences (PLSE) recently reached a key milestone with the FDA’s approval of its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, evaluating its Nanosecond Pulsed Field A ...