Boston Scientific Corp.'s Farapoint, its latest pulsed field ablation catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation, CEO Mike Mahoney reported at the J.P. Morgan Healthcare Conference in San Francisco. The newest member of the popular Farapulse family of PFA catheters provides a focal point option for creation of straight line or focal lesions, complementing the larger, single-shot Farawave catheter that has dominated the PFA market since its U.S. approval in early 2024.
Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.
At first glance, the results of the CLOSURE-AF study would seem to spell doom for left atrial appendage closure devices for patients at risk of stroke, but there is some noise in the signal, including that the devices used in the study no longer represent the state of the med-tech art.
Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after all, an outcome that qualifies as a crowd-pleaser for all but the makers of these pharmaceutical agents.
Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.
In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.
Heartbeam Inc.'s algorithms performed as well on a standard 12-lead electrocardiography (ECG) as on its 3D ECG system in the detection of atrial fibrillation, atrial flutter and sinus rhythm, based on a study presented by Joshua Lampert, cardiac electrophysiologist and medical director of machine learning at HRX Live 2025 in Atlanta.
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of pulsed field ablation for atrial fibrillation, and while several trusts in the U.K. are already using these devices for their patients, the endorsement is certain to expand utilization in the U.K., which according to data from Clarivate’s Epidemiology Intelligence may come to nearly 4 million.
The U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
