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Pulse Biosciences Breaks Ground with FDA 510(k) Approval for Cutting-Edge CellFX® nsPFA™ Percutaneous Electrode System

Pulse Biosciences has achieved a significant milestone with the FDA's clearance of its CellFX nsPFA Percutaneous Electrode System. This innovative technology is now approved for use in percutaneous and intraoperative surgical procedures to ablate soft tissue.

The CellFX nsPFA Percutaneous Electrode System utilizes Pulse Biosciences' proprietary CellFX nsPFA technology, which employs nanosecond pulsed electric fields for tissue ablation. Unlike traditional methods, this technology offers precise removal of cellular tissue without damaging noncellular structures or causing thermal necrosis.

Key components of the Percutaneous Electrode System include a percutaneous needle electrode designed for use with the CellFX nsPFA Console. This design allows for customizable energy delivery, intuitive usability, and shorter procedure times. Importantly, the system is intended for non-cardiac applications, providing physicians with a minimally invasive treatment option for soft tissue ablation. This FDA clearance represents a significant advancement for Pulse Biosciences, opening up new clinical applications and opportunities in the field of soft tissue ablation procedures.


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