The U.K. government will offer women home-testing kits for cervical screening as part of an effort to tackle barriers and get more of them taking this potentially life-saving test.
Deepecho Inc. received the U.S. FDA’s nod for its AI-based platform that assesses fetal biometry and amniotic fluid volume to improve the efficiency and precision of fetal ultrasound diagnostics.
Deski SAS raised $6 million in a seed round to support the launch of its cardiac imaging software, Heartfocus, in the U.S. The AI-driven heart exam tool helps health care professionals perform echocardiograms from any ultrasound probe to enable the early detection of heart disease.
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
Aortyx SL secured €13.8 million (US$15.9 million) in a series A funding round for its solution which treats aortic dissection. The company developed a system to repair the aortic tear, which includes a biomimetic, bioresorbable adhesive patch inserted in the aorta using an endovascular catheter and a deployer.
Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.
Aiatella Oy secured €2 million (US$2.28 million) in funding for its AI-powered cardiovascular imaging technology. The funds will be used to conduct clinical trials and develop the company’s ultrasound-based preventative screening tool, which detects and quantifies carotid artery narrowing in minutes.
