Allurion Technologies Inc. is cleared by regulators in France to resume sales of its swallowable gastric balloon to treat obesity, in the country. Last summer, the company withdrew the Allurion Balloon from the French market amid concerns about the safety of the weight loss device. The greenlight to relaunch the product is good news for Allurion given that France represents a sizeable portion of its market.
European companies looking for capital should find the fundraising environment more favorable in 2025. Private med-tech financings in January totaled about $2 billion, more than double from last year, and the venture capital firms on the continent have the funds available to pursue investment opportunities.
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
Skin Analytics Ltd. received CE mark for its AI-based tool Deep Ensemble for the Recognition of Malignancy (DERM), which can assess images of lesions and detect skin cancer autonomously. The technology has an accuracy rate of 99.8% compared to 98.9% for dermatologists.
To say that European investors are optimistic about the outlook for the med-tech sector in 2025 is an understatement. A couple of companies are already listed on public markets, acquisitions have been undertaken and med-tech players with cash-rich balance sheets are on the hunt.
C the Signs Ltd. recently received a capital injection of $8 million from Khosla Ventures to expand its AI-powered cancer prediction platform to the U.S. market.
Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.
Tensive S.r.l. raised €14 million (US$14.5 million) in a series A financing round for its bio-absorbable breast implant Regenera, for patients undergoing reconstructive surgery after lumpectomy. The funds will be used to complete a pivotal clinical trial to evaluate the safety and performance of the technology.
Neu Health Ltd. received $2 million in funding from Cedars-Sinai Intellectual Property Company and Oxford Science Enterprises (OSE) to bring its platform, designed for Parkinson’s disease and dementia care, into the U.S.
