Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.

Science Corp. raised $230 million in an oversubscribed series C financing round to commercialize its Prima brain-computer interface (BCI) retinal implant and to advance other pipeline programs into the clinic. The investment brings the company’s total funding, since founding in 2021, to approximately $490 million and shows investors growing appetite for BCI technologies.

Polares Medical SA raised $50 million in a series C financing round for Mrace, its posterior leaflet replacement system designed to treat mitral regurgitation.

Radnet Inc. acquired Gleamer SAS for up to €230 million (US$267 million) as it continues to expand its position across imaging and acute diagnostic care, while accelerating its move toward AI-powered automated diagnostics. Gleamer will be integrated into Radnet’s subsidiary, Deephealth Inc., strengthening its imaging portfolio, and positioning the company as the world’s largest provider of radiology clinical AI solutions.

The U.K.’s National Institute for Health and Care Excellence (NICE) recommendation that leadless cardiac pacemakers be used as the standard of care for people with slow heart rhythms (bradyarrhythmias) is a boon for more than 2 million individuals living with the condition. The use of the technology will transform patients’ quality of life, reduce rates of infections and lower costs for the health care system.

U.S. med-tech companies are optimistic about the year ahead and believe that they are well positioned to navigate geopolitical headwinds and the uncertainty that they bring. Their technologies, which span neurosurgery and tissue reconstruction to cardiology and radiation protection, address important clinical needs. With the major U.S. corporates accelerating dealmaking and acquisitions, these companies see strong momentum building for the year ahead.

The U.S. FDA approved Allurion Technologies Inc.’s premarket application for its swallowable gastric balloon system, which features its Smart Capsule, for weight loss. The clearance is boon for the company as GLP-1 agonists gets increasingly adopted to treat obesity. The approval also brings to the market a new non-invasive option to patients looking for alternative ways to lose weight.

This year, European med-tech companies continue to navigate an uncertain macro environment created by the reciprocal tariffs on goods entering the U.S., their primary market. Some companies though are adapting supply chains and manufacturing strategies, while others are looking to diversify into other regions. Their technologies after all, address clinical needs, so the sector continues to innovate, conduct trials, present data, raise funds, and deliver products which improve patients’ lives.

Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its IPO. Medronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months.

Neurosoft Bioelectronics SA has signed an agreement with Science Corp. to gain access to its full stack of clinical-grade neural recording tools as it looks to advance its brain-computer interface (BCI) system.