Adagio Medical (Nasdaq:ADGM) announced today that it plans a corporate restructuring and realignment of resources. The Laguna Hills, California–based company, which develops catheter ablation technologies for treating cardiac arrhythmias, wants to prioritize its FULCRUM-VT pivotal FDA investigational device exemption (IDE) clinical trial … [Read more...] about Adagio Medical to restructure, reduce workforce
Pulsed Field Ablation
Boston Scientific reports first cases with next-gen Faraflex catheter
Boston Scientific today announced the completion of the first-ever cases with its Faraflex mapping and pulsed field ablation (PFA) catheter. This latest technology marks another milestone for the Farapulse PFA portfolio. Boston Scientific initially won FDA approval for Farapulse in January 2024 and has since reported a number of significant … [Read more...] about Boston Scientific reports first cases with next-gen Faraflex catheter
Boston Scientific wins CE mark for Farapulse Nav mapping tech
Boston Scientific announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software. Farawave Nav and the Faraview software make up part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January 2024. In doing so, it … [Read more...] about Boston Scientific wins CE mark for Farapulse Nav mapping tech
Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause
This article originally ran on Feb. 15, 2025. It was updated on Feb. 28 with additional information from the FDA. Johnson & Johnson MedTech announced that it intends to resume the rollout of its Varipulse platform in the U.S. after a temporary pause. Last month, the medtech giant said it temporarily halted all U.S. cases using its … [Read more...] about Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause
Volta Medical data supports AI-guided ablation for treating AFib
Volta Medical today announced the publication of data highlighting positive outcomes for its AI-guided ablation procedure. Investigators published findings from the landmark TAILORED-AF clinical trial in Nature Medicine. Data demonstrated that an AI-guided procedure for persistent AFib in combination with conventional pulmonary vein isolation … [Read more...] about Volta Medical data supports AI-guided ablation for treating AFib
Pulse Biosciences is on track for IDE study of PFA tech this year
Pulse Biosciences (Nasdaq:PLSE) today announced feasibility study data supporting its Nanosecond PFA 360° cardiac catheter system. Along with the data, Paul LaViolette, the company's new CEO and co-chair, said Pulse Biosciences remains on track to begin an FDA investigational device exemption study this year. “[We] look forward to continuing … [Read more...] about Pulse Biosciences is on track for IDE study of PFA tech this year
CardioFocus has positive pulsed field ablation data
CardioFocus today announced the publication of 12-month data from a study of its pulsed field ablation (PFA) system. ECLIPSE AF, evaluated the safety and performance of the CardioFocus Centauri system with commercial focal ablation catheters. The first-in-human study enrolled 82 patients treated across two centers in Europe. Centauri, which … [Read more...] about CardioFocus has positive pulsed field ablation data
Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter. The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping … [Read more...] about Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech halts Varipulse cases due to stroke reports
Johnson & Johnson MedTech announced today that it "temporarily paused" all U.S. cases using its Varipulse pulsed field ablation (PFA) system as of Jan. 5. "Out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four … [Read more...] about Johnson & Johnson MedTech halts Varipulse cases due to stroke reports
Boston Scientific updates instructions for cryoablation catheters after reported deaths
The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific … [Read more...] about Boston Scientific updates instructions for cryoablation catheters after reported deaths
