The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Clinical Laboratory Association, DNA Technologies, Texas Instruments, Dialog Semiconductors, Telink Semiconductors.
With an eye toward helping those with early stage hepatocellular carcinoma (HCC), Basel, Switzerland-based Roche Group has won a breakthrough device designation from the U.S. FDA for the Elecsys GALAD score. When combined with ultrasound, the Elecsys GALAD score aims to help provide more accurate information for clinicians to treat patients at an earlier stage.
HONG KONG – Japan cuts medical device prices every two years to manage increasing health care costs. This year, the biennial medical device price cut will take effect beginning on April 1, 2020.
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.
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
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.