The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.

Neuromod Devices Ltd. raised €10 million (US$10.9 million) in financing to expand the reach of Lenire, which treats tinnitus. The fundraise, which was an expansion of its series B financing round, was led by existing investors Fountain Healthcare Partners and Panakès Partners.

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.

The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across the country and NHS England hopes that the tool will prevent around 2,000 falls and hospital admissions each day.

Relief Srl raised more than €1 million (US$1.08 million) in financing for Urorelief, its endourethral medical device which treats stress urinary incontinence. The Italian startup will use the funds to conduct clinical trials to validate the device as it looks to transform the lives of men and women suffering from the condition.

Sofinnova Partners raised a whopping €1.2 billion (US$1.26 billion) over the past year to invest in life sciences companies ranging from incubation to later-stage growth, and spanning biotech, med tech, industrial biotech and digital medicine.

Royal Philips NV recently secured EU MDR certification for the remote scanning capabilities on its Radiology Operations Command Center Console. The solution allows radiologists to remotely assist technologists in real-time by controlling scans to acquire images needed for improved diagnostic confidence and patient outcomes.

In a flurry of news releases on Feb. 27, Teleflex Inc. reported plans to buy the vascular intervention business of Biotronik SE & Co. for €760 million (US$791 million), said it intended to split into two separate public companies, floated a $300 million accelerated share repurchase program and reported the impending retirement of Chief Financial Officer Thomas Powell. The news sent the company stock down more than 20%.

There is no doubt this year started with a boom for European med-tech companies. Public markets opened in the U.S. and cross-border investors are deploying capital. With many companies looking to conduct clinical trials, raising funds and bringing their devices to the market, 2025 is expected to be prosperous, mitigating the difficulties of the previous two to three years.

A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.