Pulse Biosciences (Nasdaq:PLSE) today announced the enrollment of the first patient in its NANOCLAMP AF study for treating AFib. In September, the FDA granted investigational device exemption (IDE) for Pulse's nanosecond pulsed field ablation (nsPFA) system. Approval gave Pulse the green light to proceed with the initiation of the NANOCLAMP AF … [Read more...] about Pulse Biosciences enrolls first patient in NANOCLAMP PFA trial
Pulsed Field Ablation
Abbott gets FDA breakthrough nod for dual-energy ablation catheter
An Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter. The catheter features a dual-energy modality for the … [Read more...] about Abbott gets FDA breakthrough nod for dual-energy ablation catheter
Johnson & Johnson MedTech launches ventricular arrhythmia ablation registry
Johnson & Johnson MedTech today introduced the Collaborative Outcomes Registry for Evidence in Ventricular Arrhythmias (CORE-VA). The company announced the registry during the International Symposium on Ventricular Arrhythmias in Philadelphia. It aims to capture contemporary practice patterns in ventricular arrhythmia (VA). That includes … [Read more...] about Johnson & Johnson MedTech launches ventricular arrhythmia ablation registry
Pulse Biosciences shares strong first-in-human PFA data
Pulse Biosciences (Nasdaq:PLSE) today announced clinical study results from a first-in-human study of its nPulse system. The company shared findings from the first-in-human feasibility study of the cardiac surgical system at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. Pulse Biosciences' … [Read more...] about Pulse Biosciences shares strong first-in-human PFA data
Kardium reports first commercial cases with Globe PFA
Kardium announced today that it completed the first commercial procedures using its Globe pulsed field ablation (PFA) system. These mark the first cases with Globe, a treatment for AFib, after its recent approval by the FDA. Last month, the FDA granted Globe premarket approval (PMA), plus 510(k) clearance for the Globe introducer sheath and Globe … [Read more...] about Kardium reports first commercial cases with Globe PFA
Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
The FDA today issued a notice warning of updated instructions for the Abbott (NYSE: ABT) TactiFlex Ablation Catheter, Sensor-Enabled (SE). According to the agency, Abbott issued a letter to affected customers recommending updated instructions when removing the catheter from its packaging. The communication comes as part of the FDA's Communications … [Read more...] about Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
Pulse Biosciences wins FDA IDE to conduct study of PFA tech for AFib
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for its pulsed field ablation (PFA) system. The approval allows Pulse to proceed with the initiation of the NANOCLAMP AF study. NANOCLAMP AF evaluates the company's nanosecond PFA (nsPFA) Cardiac Surgery System for treating AFib. According … [Read more...] about Pulse Biosciences wins FDA IDE to conduct study of PFA tech for AFib
Kardium gets FDA green light for Globe pulsed field ablation system
Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software. With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like … [Read more...] about Kardium gets FDA green light for Globe pulsed field ablation system
Boston Scientific reports strong Farapulse, Watchman FLX data
Boston Scientific (NYSE: BSX) today shared positive findings from studies for its Farapulse and Watchman FLX offerings. Farapulse, a pulsed field ablation (PFA) system, provides an option to treat AFib. It received FDA approval in early 2024 and this summer picked up expanded approval. Watchman FLX, Boston Scientific's left atrial appendage … [Read more...] about Boston Scientific reports strong Farapulse, Watchman FLX data
Johnson & Johnson MedTech reports positive Varipulse study findings
Johnson & Johnson MedTech (NYSE: JNJ) today announced positive safety and effectiveness results from a substudy of its Varipulse platform. VARIPURE, a substudy of the SECURE study, evaluated Varipulsel in pulsed field ablation (PFA) procedures for treating AFib. Investigators shared results at the 2025 European Society of Cardiology (ESC) … [Read more...] about Johnson & Johnson MedTech reports positive Varipulse study findings
