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Pulse Biosciences (NASDAQ:PLSE) stock rallied 22% in morning trading Monday after the medtech company said it had received FDA breakthrough device designation for its CellFX nanosecond pulse field ablation cardiac surgery system for the treatment of atrial fibrillation, or AFib.
Pulse said it plans to pursue a premarket approval application, or PMA, from the FDA rather than a 510k approval. The company expects to begin a pivotal trial for the system for AFib in 2025, according to a statement.
Other developers of PFA systems for the treatment of AFib include Boston Scientific (BSX), Medtronic (MDT) and Johnson & Johnson (JNJ).