Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the … [Read more...] about Luma Vision wins expanded FDA nod for its cardiac procedure software
Pulsed Field Ablation
Abbott earns FDA approval for new dual-energy ablation catheter
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
Medtronic wins expanded indication in Europe for Affera to treat VT
Medtronic (NYSE: MDT) has won an expanded CE mark indication for its Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias. The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first … [Read more...] about Medtronic wins expanded indication in Europe for Affera to treat VT
Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
A Boston Scientific (NYSE:BSX) executive said today that the company enrolled the first patients in a new pulsed field ablation (PFA) trial. Nick Spadea-Anello, Boston Scientific EVP and president of Electrophysiology, shared the news of the initial enrollments on LinkedIn. Dr. Andrea Natale and the Texas Cardiac Arrhythmia Research team at St. … [Read more...] about Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA approval for its dual-energy ThermoCool SmartTouch SF platform (DE STSF). The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of … [Read more...] about Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson begins carotid IVL study enrollment
Johnson & Johnson (NYSE:JNJ) today announced the initiation of its SKYWARD clinical program for a new Shockwave IVL system. The SKYWARD FDA investigational device exemption (IDE) study evaluates the novel SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries prior to stenting. SkyRunner, … [Read more...] about Johnson & Johnson begins carotid IVL study enrollment
Johnson & Johnson launches ThermoCool SmartTouch ablation tech in Europe
Johnson & Johnson (NYSE:JNJ) announced today that it launched its dual-energy ThermoCool SmartTouch platform in Europe. The launch expands access in the region to dual-energy catheter ablation for personalized care across workflows, anatomies and procedural strategies. J&J's ThermoCool SmartTouch platform combines the ThermoCool … [Read more...] about Johnson & Johnson launches ThermoCool SmartTouch ablation tech in Europe
Medtronic brings PulseSelect pulsed field ablation tech to India
Medtronic (NYSE:MDT) announced the launch of its PulseSelect pulsed field ablation (PFA) platform in India. PulseSelect uses non-thermal energy to deliver cardiac ablation to treat AFib. The energy delivers pulmonary vein isolation while reducing the risk of damage to surrounding structures. Medtronic's system features nine electrodes on its … [Read more...] about Medtronic brings PulseSelect pulsed field ablation tech to India
Adagio submits ventricular ablation system to FDA
Adagio Medical (Nasdaq:ADGM) announced today that it submitted its premarket approval (PMA) application to the FDA for its vCLAS system. The company submitted its vCLAS ventricular ablation system for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic … [Read more...] about Adagio submits ventricular ablation system to FDA
Pulse Biosciences has positive PFA data at HRS 2026
Pulse Biosciences (Nasdaq:PLSE) today announced new positive clinical findings for its nPulse cardiac catheter system. nPulse uses proprietary nanosecond pulsed field ablation (nsPFA) energy to deliver a complete circumferential lesion in a single, brief energy application without the need to stack lesions. It also eliminates the need to stop, … [Read more...] about Pulse Biosciences has positive PFA data at HRS 2026
