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Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. Read More
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. Read More
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Read More
FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA. Read More
Myomo is a developer of wearable robotic devices that provide improved arm and hand function for patients with upper limb paralysis and neurological disorders. Read More
“We recommended that CMS adapt and streamline existing processes to allow for rapid reviews of breakthrough devices, while still fully considering the evidence needed to ensure their safety and effectiveness,” AHIP said. Read More
The test runs on Ortho’s Vitros platform, using swab samples that can be stored at room temperature for up to two days and will become available worldwide in large supply this month. Read More
“This acquisition enhances our global market position in trauma and extremities, providing significant opportunities to advance innovation, improve outcomes and reach more patients,” said Stryker Chairman and CEO Kevin Lobo. Read More