Pulse Biosciences Files 510(k) Submission With FDA For Its CellFX NsPFA

(RTTNews) - Pulse Biosciences, Inc. (PLSE) Tuesday announced the filing of a premarket notification 510(k) to FDA for its CellFX Nanosecond Pulsed Field Ablation or nsPFA percutaneous electrode for the treatment of atrial fibrillation.

The 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 noncellular structures. It is designed for non-cardiac applications.

The company noted that Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information based on that review.

FDA guidance suggests the goal is to complete 510(k) substantive review within 90 calendar days.