Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode

Pulse Biosciences, which is primarily focused on its CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for atrial fibrillation, recently announced it has filed a premarket notification 510(k) submission to FDA for its CellFX nsPFA percutaneous electrode.

The percutaneous electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver nonthermal ablation of cellular tissue without damaging noncellular structures. Of note, the electrode is designed for non-cardiac applications, according to the company.

Once the application is accepted by FDA, it will be put under substantive review, including the potential for requests of additional information from the company.

“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 CEO of Pulse Biosciences, in a press release. “We look forward to collaborating with the FDA throughout the review process.”