By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley From pulsed field ablation to diabetes, surgical robotics, and much more, we see a number of significant medical device launches on the horizon in 2024. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston […]
Pulsed-Field Ablation (PFA)
Abbott increases guidance on strong Q1 results, reports progress on Volt PFA system
Abbott shares fell this today despite first-quarter results that came in ahead of the consensus forecast. Shares of ABT fell more than 3% to $105.81 apiece by later afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped slightly. The Abbott Park, Illinois-based medtech giant […]
Biosense Webster reports positive dual-energy ablation results
Johnson & Johnson’s Biosense Webster unit today announced positive three-month follow-up results from its SmartfIRE clinical trial. The study evaluated the use of the dual-energy ThermoCool SmartTouch SF catheter. ThermoCool SmartTouch SF is the first dual-energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index. Biosense Webster’s system in […]
Medtronic has positive data for single-shot mapping ablation catheter
Medtronic today announced positive clinical trial data for its Sphere-360 investigational pulsed field ablation (PFA) catheter technology. The single-shot mapping and ablation catheter uses pulsed field energy to treat patients with paroxysmal AFib. Medtronic presented interim findings on the system at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting. Designed with the goal to […]
Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific announced today that it began a new study of its Faraview software module for the Farawave pulsed field ablation (PFA) catheter. The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave Nav catheter expand the capabilities of the Boston Scientific […]
Pulse Biosciences to raise $60M
Pulse Biosciences (Nasdaq:PLSE) announced that its board of directors approved plans to initiate a rights offering worth $60 million. The offering features up to $60 million in the form of “units” available to all holders of the company’s common stock. Each unit consists of one share of common stock and warrants to purchase a total […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system. The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. CellFX nsPFA’s percutaneous electrode system features a percutaneous needle […]
J&J Biosense Webster’s Varipulse PFA system wins CE mark
J&J MedTech’s Biosense Webster unit announced today that it won CE mark approval for its Varipulse pulsed field ablation (PFA) platform. European officials approved Varipulse for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto […]
Argá Medtech closes oversubscribed Series B funding for pulsed field ablation tech
Argá Medtech today announced it closed a €54 million oversubscribed Series B funding round to support its pulsed field ablation technology. The Lausanne, Switzerland-based company develops the Coherent Sine-Burst Electroporation pulsed field ablation system for treating cardiac arrhythmias, including atrial fibrillation. Argá’s latest financing will allow the company to advance the development of its CSE […]
Boston Scientific completes first commercial Farapulse cases in U.S.
Boston Scientific has completed the first post-FDA approval cases in the U.S. with its Farapulse pulsed field ablation system. In a LinkedIn post, Nick Spadea-Anello, president, Electrophysiology, Boston Scientific, announced the first commercial use for the AFib treatment. Marlborough, Massachusetts-based Boston Scientific won the approval for Farapulse last month. In doing so, it became second […]