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Pulsed Field Ablation

Abbott earns FDA approval for Volt PFA system for AFib

December 22, 2025 By Sean Whooley

Abbott Volt PFA catheter

Abbott (NYSE:ABT) announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib. The regulatory nod brings Abbott Volt to the U.S. PFA market to compete against the likes of Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium. It follows CE mark approval for Volt earlier this … [Read more...] about Abbott earns FDA approval for Volt PFA system for AFib

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: Abbott, fda

HRS launches data registry for PFA that treats AFib, J&J announces sponsorship

December 19, 2025 By Sean Whooley

Johnson & Johnson MedTech Biosense Webster Varipulse catheter PFA

Johnson & Johnson MedTech today announced its sponsorship of a new PFA data collection platform from the Heart Rhythm Society (HRS). HRS aims to capture real-world data on pulsed field ablation (PFA) procedures used to treat AFib. The first-of-its-kind registry will offer a long-term data collection platform, J&J MedTech said in a news … [Read more...] about HRS launches data registry for PFA that treats AFib, J&J announces sponsorship

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Heart Rhythm Society, Johnson & Johnson, johnson & johnson medtech

Pulse Biosciences wins FDA IDE to study PFA tech

December 18, 2025 By Sean Whooley

Pulse BioSciences CellFX nsPFA percutaneous electrode system

Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted an investigational device exemption (IDE) for a pulsed field ablation (PFA) study. The IDE enables the Hayward, California–based company to initiate the NANOPULSE-AF study of its nPulse cardiac catheter ablation system. The study evaluates the company's PFA technology in the … [Read more...] about Pulse Biosciences wins FDA IDE to study PFA tech

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: fda, Pulse Biosciences

Pulse Biosciences to evaluate PFA in treating thyroid cancer

December 9, 2025 By Sean Whooley

Pulse Biosciences Logo

Pulse Biosciences (Nasdaq:PLSE) today announced a collaboration aimed at using its pulsed field ablation (PFA) technology for thyroid cancer treatment. The Hayward, California-based company entered into a research collaboration with the University of Texas MD Anderson Cancer Center. They aim to examine the use of the nPulse Vybrance percutaneous … [Read more...] about Pulse Biosciences to evaluate PFA in treating thyroid cancer

Filed Under: Catheters, Pulsed Field Ablation, Research, Research & Development, Technologies & Devices Tagged With: Pulse Biosciences

Boston Scientific gets European nod for Farapoint catheter

December 4, 2025 By Sean Whooley

Boston Scientific Farapoint catheter as part of the Farapulse PFA system (1)

Boston Scientific announced recently that it received CE mark for its Farapoint pulsed field ablation (PFA) catheter. The regulatory nod, earned last week, allows the Marlborough, Massachusetts-based company to bring the newest PFA catheter in its electrophysiology portfolio to the European market. Farapoint treats right atrial flutter (AFL), … [Read more...] about Boston Scientific gets European nod for Farapoint catheter

Filed Under: Applications, Cardiology, Catheters, CE Mark, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: Boston Scientific

CMS adds reimbursement for cardiac ablation in ASCs

November 24, 2025 By Sean Whooley

This image shows the variety of shapes and sizes of pulsed field ablation catheters, showing from top to bottom catheteres used in Boston Scientific's Farapulse, Medtronic's Affera, Medtronic's Pulse Select, J&J's Varipulse, and Abbott's Volt.

The Centers for Medicare and Medicaid Services (CMS) has provided a major reimbursement update for cardiac ablation technologies. In its 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule, CMS added cardiac catheter ablation procedures to its ASC-covered procedures list. This … [Read more...] about CMS adds reimbursement for cardiac ablation in ASCs

Filed Under: Applications, Business, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Boston Scientific, Centers for Medicare and Medicaid Services (CMS), CMS, johnson & johnson medtech, medtronic

Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal

November 13, 2025 By Sean Whooley

Boston Scientific Watchman FLX Siemens Healthineers AcuNav Volume 4D ICE Catheter

Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] today announced a catheter development and commercialization deal with Siemens Healthineers. The deal centers around the workflow development and commercialization of Siemens Healthineers' AcuNav 4D intracardiac echocardiography (ICE) catheter. AcuNav 4D ICE technology is … [Read more...] about Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal

Filed Under: Applications, Business, Cardiac Implants, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Boston Scientific, Siemens Healthineers

Boston Scientific enrolls first patient in AFib mapping study using OptiMap, Farapulse

November 12, 2025 By Sean Whooley

Boston Scientific OptiMap Cortex OPTIMIZE trial graphic

A Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] official announced the enrollment of the first patients in the OPTIMIZE randomized controlled clinical trial. On LinkedIn, Nick Spadea-Anello, the company’s president of Electrophysiology, announced the enrollment in the trial. He said Dr. Oussama Wazni, global principal … [Read more...] about Boston Scientific enrolls first patient in AFib mapping study using OptiMap, Farapulse

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Boston Scientific

CardioFocus enrolls first patients in PFA trial as it seeks European approval

November 11, 2025 By Sean Whooley

CardioFocus Logo (1)

CardioFocus announced today that it initiated clinical trials for its next-generation pulsed field ablation (PFA) technologies. The company kicked off its CE mark pivotal trial for the QuickShot Nav large-area focal PFA catheter and its next-generation CardioWave PFA system. Dr. Ante Anić leads the study, which enrolled the first patients at KBC … [Read more...] about CardioFocus enrolls first patients in PFA trial as it seeks European approval

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Cardiofocus

Galvanize reports promising early results for pulsed electric field ablation for oncology

November 11, 2025 By Sean Whooley

Galvanize Therapeutics Aliya pulsed electric field ablation

Galvanize Therapeutics today announced the publication of positive six-month results from its AFFINITY clinical trial in the medical journal Cancers. AFFINITY, a prospective, non-randomized, open-label, single-arm study evaluates the safety and feasibility of the company's Aliya platform. Aliya, a pulsed electric field (PEF) system, could … [Read more...] about Galvanize reports promising early results for pulsed electric field ablation for oncology

Filed Under: Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Galvanize Therapeutics

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