Medtronic plc obtained a CE mark for its next generation Endoflip 300 system which measures pressure and dimensions in the esophagus and pylorus, in adults. The Endoflip can be used to help diagnose and treat thousands of people across Europe suffering with esophageal motility disorders.
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
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).