Abbott Laboratories snagged a CE mark for its Volt pulsed field ablation catheter for atrial fibrillation several months earlier than the mid-year approval expected. The Abbott Park, Ill.-based company has begun Volt’s commercial launch with the physicians who participated in its European clinical trials and plans to expand to other users on the continent in the second half of 2025.

At the four-day KIMES 2025 exhibition, more than 35,000 products and prototypes were on display. In the clamor, BioWorld engaged with three promising neurological disease-focused companies – Readycure Inc., Neurive Co. Ltd. and Vuno Inc. – that showcased innovative technology for conditions like Alzheimer’s disease and tinnitus at the Seoul-based event.

The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.

Brainomix Ltd. raised £14 million ($18 million) in a series C financing round to expand its AI-powered imaging solution, Brainomix 360 Stroke, into the U.S. market. Funds will also go towards advancing the Brainomix 360 E-Lung, which can accurately predict the progression of lung fibrosis. “This series C round is a vital fundraise for us,” Michalis Papadakis, CEO and co-founder of Brainomix, told BioWorld. “We are in a growth stage where we want to bring this next generation of stroke AI into the U.S. market.”

New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.

With its Altix AI.i launch, GE Healthcare Technologies Inc. aims to upgrade the user experience and efficiency of its catheterization lab and electrophysiology procedures. The new capabilities apply to the Cardiolab, Mac-Lab and Combolab products. The Alitx Ai.i software upgrades received U.S. FDA clearance in December. CE mark is pending.

An Australian man in his 40s with severe heart failure was implanted with a Bivacor Inc. total artificial heart (TAH) and has been discharged from the hospital. He remained at home with the artificial heart for 100 days until he received a transplant earlier this week.

Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden at the Cardiovascular Research Technologies 2025 meeting in Washington.

Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.

With more than three weeks left in the first quarter, the value of med-tech IPOs for 2025 already exceeds the funds raised from all IPOs for med-tech companies in the last two years combined. Kestra Medical Technologies Ltd. provides a clear example of how fast the market is heating up, with a final IPO that raked in more than twice as much as initially expected, while Advanced Biomed Inc. shows the appeal of the U.S. exchanges for non-U.S. companies.