Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.

Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.

Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.

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.

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.

Stimvia s.r.o. recently secured Medical Device Regulation certification for its Uris neuromodulation system to deliver both percutaneous tibial nerve stimulation and peroneal electrical transcutaneous neuromodulation to treat lower urinary tract symptoms.

Edwards Lifesciences Corp. continued its recent acquisition streak with its buy of JC Medical Inc., a subsidiary of Genesis Medtech International. The sale included the intellectual property and commercial rights for the J-Valve system, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation.

It’s a quad-pack for Edwards Lifescience Corp. as it reported its third and fourth deals this month – agreements to buy Jenavalve Technology Inc. and Endotronix Inc. for a combined up-front cost of about $1.2 billion plus up to $445 million in contingent milestone payments.

Edwards Lifesciences Inc. struck three deals totaling €15 million (US$16.3 million) with Affluent Medical SAS to gain access to its mitral valve technology. Edwards secured an exclusive option to acquire Affluent subsidiary Kephalios, which makes the Kalios adjustable mitral ring, for €5 million (US$5.44 million); paid €5 million more for global, non-exclusive licensing of Affluent’s intellectual property related to its biomimetic cardiac mitral valve replacement technology; and invested a further €5 million to acquire 9.21% of Affluent.

Uromems SAS raised $47 million in a series C financing round for its Uroactive system, the first smart automated artificial urinary sphincter device to treat stress urinary incontinence. With the funds the company will be able to “tackle the last stage of our clinical trials before commercial launch,” Hamid Lamraoui, CEO and co-founder of Uromems, told BioWorld.