The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being. Read More
COVID-19 vaccine developers should begin testing their vaccines against emerging variants now and assessing booster regimens, the FDA said in an update to its October guidance on emergency use authorizations (EUAs) for the vaccines. Read More
The U.S. FDA has given a green light to Brainlab AG for two new additions to its robotic surgery systems. The agency granted 510(k) clearances for the Loop-X mobile imaging robot and the Cirq Robotic Alignment module for spine procedures, paving the way for U.S. market entry. Read More
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA. Read More
Organoids grown from cholangiocytes – the epithelial cells of the bile duct – are poised to be used in ex vivo cell therapy to increase the number of donated livers that are suitable for transplant, and also for direct bile duct repairs. The organoids have been shown to be effective in correcting defects in mouse models and in perfused donated livers. They are now being tested in large animal models. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Brainstorm Cell Therapeutics, Gala Therapeutics, Integral Diagnostics, Lightdeck Diagnostics, Lucid Diagnostics, Medica, Mediwound, Nuprobe, Paragonix, Pavmed, Pre Diagnostics, Scanwell Health, Seaspine, Solys Diagnostics, Spineway, Tsunami Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Piccolo Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada clarified RUO policy. Read More
Keeping you up to date on recent developments in cardiology, including: Algorithm can make echocardiography a breeze for the inexperienced; Algorithm suppresses CT scan time in chest imaging studies; Study shows distal radial access better for occlusion. Read More
