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.

Qaelon Medical SAS partnered with Caresyntax GmbH, aiming to build the first real-world evidence platform to tackle problems associated with surgical leaks. The companies hope their solution will provide real-time information to surgeons, improving outcomes and making surgery safer for patients.

Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy.

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.

Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.

Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.

Balt Group SAS recently secured €355 million (US$365 million) in funding to refinance its debt, invest in research and accelerate its growth. The French-based provider of interventional neuroradiology devices is looking to speed up the expansion of its global footprint, especially in the U.S.

Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.

The U.K. government will unveil its 10-year health plan to transform the national health service (NHS) in the coming months. At the center of this transformation is expected to be the adoption of artificial intelligence, digital and medical technologies. However, challenges in the NHS around its ‘core technology’, data capture and interoperability must be addressed before the government’s ambition can be realized.

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.