The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.

Owlstone Medical Ltd. recently secured $27 million in the first close of its series E financing round for clinical trials and product commercialization based on its Breath Biopsy platform technology. The fundraise was led by Ventura Capital, joined by Aviva Ventures, Horizons Ventures and other existing investors.

The U.K.’s Buckinghamshire NHS Trust has partnered medical technology design experts from Team Consulting Ltd. to create a tool that can transform burn care treatment. The concept training tool incorporates mixed reality which maps ‘custom digital burns’ onto a mannequin to enable surgeons to explore a diverse range of burn types and patient profiles and deliver better outcomes.

At least half of women experience urinary incontinence at some point in their lives but few discuss the condition with their physicians. In part, that’s because most women believe few effective treatments exist for urinary leakage – and until recently, they were right. Several advances in 2024, however, offer new hope.

Esocap AG aims to transform the treatment of eosinophilic esophagitis with its drug delivery technology, ESO-101, designed to increase mucosal contact time and drug deposition in the esophagus. Data from the recent ACESO study showed that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in patients with active eosinophilic esophagitis.

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.