Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device designation. The medtech giant said the FDA granted breakthrough device designation for its Sphere-9 catheter for the treatment of ventricular tachycardia (VT). At Heart Rhythm Society (HRS) 2026 in Chicago, the company … [Read more...] about Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera
Pulsed Field Ablation
Boston Scientific studies back Farawave, Faraflex, Watchman FLX Pro and more
Boston Scientific (NYSE:BSX) today shared new clinical findings supporting its wide-ranging electrophysiology (EP) portfolio. The Marlborough, Massachusetts-based company shared its findings, covering pulsed field ablation (PFA) and combined approaches with left atrial appendage closure (LAAC) to treat AFib, reduce stroke risk and support … [Read more...] about Boston Scientific studies back Farawave, Faraflex, Watchman FLX Pro and more
Abbott data at HRS 2026 backs PFA, pacing systems
Abbott (NYSE:ABT) today shared new study findings supporting its pulsed field ablation (PFA) and conduction system pacing (CSP) systems. At Heart Rhythm Society (HRS) 2026 in Chicago, the company shared data from four trials backing the portfolios. Findings included six-month data from the FlexPulse IDE study evaluating the TactiFlex … [Read more...] about Abbott data at HRS 2026 backs PFA, pacing systems
Johnson & Johnson launches head-to-head PFA trial pitting Varipulse against Boston Scientific’s Farapulse
Johnson & Johnson (NYSE:JNJ) today announced the initiation of a new trial evaluating competitive pulsed field ablation (PFA) technologies. The PERSIGMA RCT pits the company's Varipulse Pro PFA platform against the Boston Scientific Farapulse system. It compares the two leading PFA therapies in treating persistent AFib. Varipulse Pro, which … [Read more...] about Johnson & Johnson launches head-to-head PFA trial pitting Varipulse against Boston Scientific’s Farapulse
Stereotaxis reports first US procedures with MAGiC ablation catheter
Stereotaxis (NYSE:STXS) today announced the first patients successfully treated in the U.S. with its MAGiC system. MAGiC (magnetic interventional ablation catheter) delivers radiofrequency cardiac ablation to treat heart arrhythmia. The technology received FDA clearance at the start of this year, joining the FDA-cleared MAGiC Sweep robotically … [Read more...] about Stereotaxis reports first US procedures with MAGiC ablation catheter
Protaryx earns FDA nod for transseptal puncture device
Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device. Baltimore-based Protaryx said clearance marks a significant advancement in its mission to redefine safe, efficient and reproducible left heart access. for cardiac interventions. It hopes to enable broader adoption and improved … [Read more...] about Protaryx earns FDA nod for transseptal puncture device
Johnson & Johnson reports positive Varipulse results at EHRA 2026
Johnson & Johnson today announced positive 12-month interim effectiveness and safety results from a study of its Varipulse system. Varipulse, the medtech giant's pulsed field ablation (PFA) platform, is designed to streamline ablation and mapping through a single integrated workflow with the Carto 3 mapping system. Carto 3 offers 3D heart … [Read more...] about Johnson & Johnson reports positive Varipulse results at EHRA 2026
Pulse Biosciences names Liane Teplitsky as new COO
Pulse Biosciences (Nasdaq:PLSE) announced today that it appointed Liane Teplitsky as its new COO to further bolster its leadership team. Hayward, California-based Pulse Biosciences also expanded the role of Dr. David Kenigsberg to full-time chief medical officer (CMO). The pulsed field ablation (PFA) technology developer says the appointments … [Read more...] about Pulse Biosciences names Liane Teplitsky as new COO
Pulse Biosciences enrolls first patient in IDE study for PFA tech
Pulse Biosciences (Nasdaq:PLSE) announced today that it enrolled the first patients in its NANOPULSE-AF study. NANOPULSE-AF, an FDA investigational device exemption (IDE) study, evaluates the nPulse cardiac catheter system in the treatment of recurrent, drug-resistant, symptomatic paroxysmal AFib. Hayward, California-based Pulse Biosciences … [Read more...] about Pulse Biosciences enrolls first patient in IDE study for PFA tech
Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
Johnson & Johnson (NYSE:JNJ) announced today that it launched the Varipulse Pro system in Europe following CE mark approval. Varipulse Pro features a new pulse sequence that marks the next evolution of the pulsed field ablation (PFA) platform. The company said it designed the technology to improve procedural efficiency while reinforcing … [Read more...] about Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
