Pulse Biosciences Announces FDA 510(k) Clearance for its CellFX® nsPFA™ Percutaneous Electrode System [Yahoo! Finance]
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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Source: Yahoo! Finance
Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 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," said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. "Internally, our team is pleased with its manufact
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