HAYWARD, Calif. - Pulse Biosciences, Inc. (NASDAQ:PLSE), a bioelectric medicine company, has announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX Nanosecond Pulsed Field Ablation (nsPFA) Percutaneous Electrode System. This system is intended for use in the ablation of soft tissue during percutaneous and intraoperative surgical procedures.
The CellFX nsPFA Percutaneous Electrode System employs a percutaneous needle electrode that works with the company's CellFX nsPFA Console. The technology behind this system is designed to precisely remove cellular tissue without affecting noncellular structures or causing thermal necrosis, which is the death of cells due to excessive heat.
The FDA clearance marks a significant milestone for the company in the surgical field, providing a new set of clinical applications for its proprietary technology. Kevin Danahy, President and CEO of Pulse Biosciences, expressed pride in the company's teams for their dedication to making nsPFA technology available to physicians and patients. He also noted the company's readiness for initiating training and commercialization programs in the upcoming weeks.
Dr. Ralph P. Tufano, Senior Advisor and Chair of the Scientific Advisory Board at Pulse Biosciences, emphasized the system's promise as a minimally invasive treatment option. He cited early study results that demonstrated rapid clearance of ablated tissue and the absence of thermal damage or scarring.
Pulse Biosciences is focused on developing its CellFX nsPFA technology for various medical applications, including the treatment of atrial fibrillation. The company's technology aims to improve the quality of life for patients by delivering nanosecond pulses of electrical energy to clear cells non-thermally while sparing adjacent noncellular tissue.
This news is based on a press release statement from Pulse Biosciences, Inc.
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