The sedate uptake of pulsed field ablation (PFA) in Europe failed to presage the enthusiasm that drove the technology’s extraordinarily rapid adoption in the U.S. in 2024. Used to treat atrial fibrillation, PFA received its first U.S. FDA approval in Dec. 2023. At the time, Clarivate estimated that PFA had 7% of the global cardiac ablation market. By year-end 2024, it had 20% and Boston Scientific Corp. projected that PFA would represent up to half of the market by the close of 2025.

Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.

Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external evaluation.” So far, just 130 cases have been completed in the U.S. since the company received U.S. FDA approval in November for use in paroxysmal atrial fibrillation.

An artificial intelligence-based tool developed by researchers in the U.K. is helping doctors identify people at risk of developing atrial fibrillation. Data from the ongoing Find-AF pilot study shows that the algorithm can comb through patients’ electronic health records and detect red flags which could indicate whether they are at risk of developing the heart condition.

Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.

Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration’s approval of its Magbot magnetic navigation ablation catheter Dec. 9 for use with Stereotaxis’ robotic ablation system to treat drug-resistant cardiac arrhythmias in China.

Three years after the U.S. FDA approval of Abbott Laboratories’ Amplatzer Amulet, results of its investigational device exemption trial failed to notably differentiate Abbott’s left atrial appendage occluder system from Boston Scientific Corp.’s market-dominant Watchman device beyond the ability to forego anticoagulants quickly after implantation.

Boston Scientific Corp.’s OPTION study demonstrated left atrial appendage closure with the Watchman Flx device reduced risk of stroke compared to management with direct oral anticoagulants or warfarin in patients with atrial fibrillation following cardiac ablation. Results were presented at the American Heart Association's Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.

Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.