Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
The EU is to harness the “silver economy” of its aging population to help drive innovation and growth as part of a new strategy to make Europe “the most attractive place in the world for life sciences by 2030.”
The U.K. government revealed its much anticipated 10-year plan to get the National Health Service back on its feet and fit for the future. It is betting on five technologies – data, AI, Genomics, wearables and robotics – to drive the change needed to transform the health care system.
The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. returned to buy the company. This morning, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
The Medical Device Coordination Group (MDCG) posted a guidance document tackling the interaction between the Artificial Intelligence Act and the twin EU regulations for devices and diagnostics, but the lack of standards for AI development promises to impede efforts to bring these AI algorithms to the European market.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
Anaconda Biomed SL recently received CE mark for the Ana5 funnel catheter, designed to improve mechanical thrombectomy in the treatment of acute ischemic stroke. The company hopes that the device, which has a vessel-matching diameter funnel to maximize the capture of blood clots, could be the holy grail in mechanical thrombectomy.
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.