Pulse Biosciences announces FDA 510(k) clearance for CellFX system

Pulse Biosciences announced receipt of U.S. Food and Drug Administration 510(k) clearance for its novel CellFX nsPFA Percutaneous Electrode System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. “The FDA clearance of our Percutaneous Electrode System is the initial major milestone for Pulse Biosciences in surgery. It opens a new set of clinical applications and opportunities wherein our proprietary, one of a kind, patented CellFX nsPFA technology is highly differentiated and holds the potential to change the present time standard of care. I couldn’t be more proud of the engineering, clinical and regulatory teams at Pulse Biosciences for their commitment to bringing the safety and effectiveness benefits of nsPFA to our physician, caretaker and patient partners. Internally, our team is pleased with its manufacturing and operational readiness as we initiate our training and commercialization programs in the coming weeks. We look forward to providing additional details and color on these commercial programs in our upcoming fourth quarter and full year 2023 earnings conference call scheduled for Thursday, March 28,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences.