With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.
BOGOTA, Colombia – Argentina is the latest member of an international medical devices regulatory group. Joining the group could help the country speed up approvals and help the market for medical technology improve.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
Synaptive Medical Inc., of Toronto, has secured Health Canada’s approval for Evry, the company’s superconducting head magnetic resonance imaging (MRI) system. The Evry system aims to provide imaging directly at the point of care in areas outside diagnostic imaging departments.
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020.
The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.