The European Commission approved up to €403 million ($472 million) in funding to support development of innovations in medical devices in the region. The funds will go towards 10 companies that incorporate novel digital and AI features into their solutions.
Roche Holding AG received CE mark for its Elecsys pTau181 test to help rule out Alzheimer’s disease. The minimally invasive blood test, developed in collaboration with Eli Lilly and Co., measures phosphorylated Tau 181 protein, a biomarker indicative of amyloid pathology, a hallmark of Alzheimer’s.
Modi Ventures closed its second fund with total commitments of $88 million as it continues its mission to invest in companies at the intersection of artificial intelligence, biology and medical technology. The venture capital firm sees the future of health care as a convergence of these technologies.
Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.
Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes.
Xeltis BV is seeing encouraging preliminary data for Xabg, its coronary artery bypas conduit, from two clinical trials underway in Europe and South America. The data shows positive safety and patency in patients with multi-vessel atherosclerotic coronary artery disease.
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.
Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.
Comphya SA raised CHF 7.5 million (US$ 8.4 million) in a series A round for its implantable neurostimulation therapy, Caverstim, which treats men with erectile dysfunction who do not respond to medication.
