Pulse Biosciences has announced the filing of a premarket notification 510(k) to the US Food and Drug Administration (FDA) for its novel CellFX nanosecond pulsed field ablation (nsPFA) percutaneous electrode.
The company’s percutaneous electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver precise and complete non-thermal ablation of cellular tissue without damage to non-cellular structures. The percutaneous electrode is designed for non-cardiac applications.
“We are very happy to make this announcement earlier than expected in part due to the efficiency of the FDA’s new electronic submission platform,” said Kevin Danahy, president and chief executive officer of Pulse Biosciences. “We look forward to collaborating with the FDA throughout the review process.”
