Sign up for the QMED & MD+DI Daily newsletter.
Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode
The electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver nonthermal ablation of cellular tissue without damaging noncellular structures.
November 21, 2023
1 Min Read
Sarah Silbiger / Stringer / Getty Images News via Getty Images
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.”
About the Author(s)
Managing Editor, MD+DI
Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].
You May Also Like
Sustainable Manufacturing Expo Hits North AmericaFeb 22, 2024|4 Min Read
Medtronic Doubles Down on Sustainability EffortsFeb 22, 2024|1 Min Read
Top Medical Device M&AFeb 21, 2024|1 Min Read
FDA Urges Independent Verification of Third-Party Testing DataFeb 21, 2024|2 Min Read