Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With drugs such as Leqembi and Kisunla gaining U.S. FDA approval to treat the devastating neurological condition, the company is seeing increasing demand for its system, Neurolf CEO and co-founder Jannis Fischer, told BioWorld.
Nua Surgical Ltd. secured €6.5 million ($6.9 million) in series A financing to support regulatory clearance in the U.S. and early commercialization of its Stericision C-section retractor. The device is a self-retaining surgical retractor designed to improve outcomes for mothers undergoing a caesarean section.
52 North Health Ltd. raised $6 million in financing to bring its oncology products to the market including the Neutrocheck, a point-of-care device and app which monitors cancer patients at home at risk of developing neutropenic sepsis.
The recent $73 million raised by Cradle NV in a series B financing round will allow the company to build out its operations and improve its artificial intelligence-powered protein engineering platform.
The U.K.'s Medicines and Health Care Products Regulatory Agency chose five technologies for its AI Airlock pilot program as it looks to understand the best way to regulate artificial intelligence-powered medical devices so that they can be safely deployed across the national health service.
Neo Medical SA received certification under the EU Medical Device Regulation for its entire portfolio of spine surgical technologies. The approval means that the company can continue selling its products, which helps with the surgical treatment of back pain, across markets in Europe as they are in compliance with the high-quality control standards required for medical devices.
Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market.
An artificial intelligence-powered contactless monitoring device developed by Albus Health Ltd. can detect signs of asthma attacks in children up to five days before they occur.
Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.
Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.
