Pulse Biosciences (NASDAQ:PLSE) announced today that it has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its CellFX nsPFA Cardiac Surgery System, aimed at treating atrial fibrillation.

The company's bipolar clamp, leveraging proprietary nanosecond PFA technology, is designed to create durable, transmural ablation lesions quickly during cardiac surgery.

Dr. Niv Ad, Chief Science Officer of Cardiac Surgery at Pulse Biosciences, expressed enthusiasm about the technology, stating, “The science behind nanosecond pulse field ablation was immediately compelling to me. The preclinical data convinced me this technology could significantly advance the surgical treatment of atrial fibrillation.”

The company now plans to pursue premarket approval and aims to initiate clinical trials in 2025.