Pulse Biosciences wins FDA breakthrough nod for AFib-treating pulsed field ablation tech

Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement.

Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA cleared earlier this year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

The FDA granted the breakthrough nod for the company’s Cardiac Surgery System for ablating cardiac tissue to treat AFib. This system, which features a surgical clamp, produces durable, continuous transmural ablation lesions during cardiac surgery. The bipolar clamp utilizes the proprietary nsPFA technology.

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