Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation.
Ifast Diagnostics Ltd. raised $6.5 million (£5 million) in seed funding to bring its rapid Antimicrobial Susceptibility Testing (AST) platform to the market. The company’s technology is vital in the fight against antimicrobial resistance and the funds will be used to conduct clinical trials to get the product to the market in the U.K., U.S. and EU, CEO Toby King, told BioWorld.
Ifast Diagnostics Ltd. raised $6.5 million (£5 million) in seed funding to bring its rapid Antimicrobial Susceptibility Testing (AST) platform to the market. The company’s technology is vital in the fight against antimicrobial resistance and the funds will be used to conduct clinical trials to get the product to the market in the U.K., U.S. and EU, CEO Toby King, told BioWorld.
Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage renal disease to receive their treatment in the comfort of their own homes and without a rigid dialysis schedule.
Data from two Alzheimer’s tests being developed by Roche Holding AG showed high accuracy in detecting the disease in patients being tested for the condition. The tests measure biomarkers in the blood linked to Alzheimer’s and will help provide desperately needed information by letting patients know whether they have the disease or not, Margherita Carboni, Neurology Indication Lead at Roche Diagnostics told BioWorld.
The U.K. government is partnering with Oxford Nanopore Technologies plc to use its sequencing technology to create the world’s-first ‘early warning system’ for future pandemics. The partnership includes the development of a pathogen-agnostic biosurveillance system across the national health service (NHS).
415 Capital Management GmbH launched its second fund as it looks to raise €150 million (US$165 million) to invest in companies developing medical technologies to address cardiovascular and neurovascular diseases.
Inbrain Neuroelectronics SL closed a $50 million series B financing round to advance clinical trials for its graphene-based brain-computer interface therapeutics platform. The company also secured additional funding from Merck KGaA GmbH which will go towards developing the technology for application across both central and peripheral nervous systems.
Nyxoah SA recently raised $27 million after selling three million shares in a bid to shore up its capital base as it prepares to commercialize Genio — its obstructive sleep apnea technology — in the U.S.
The U.S. FDA granted Momentis Surgical Ltd. 510(k) clearance for its Anovo robotic surgical platform for use in single site, abdominal access ventral hernia repairs. The U.S. regulatory agency also gave the greenlight to CMR Surgical Ltd.’s Versius system for use in cholecystectomy, in a sign of the growing market for smaller, more portable robotic devices to assist in minimally invasive procedures.
