September 9, 2022
Via: Medical Device NetworkThe National Institutes of Health (NIH) is seeking the next generation of Covid-19 diagnostics, with a focus on improved performance and accessibility. As part of this move, NIH has granted two new funding opportunities, which are part of the Rapid […]
February 3, 2022
Via: FierceHealthcareStarting this spring, Medicare beneficiaries can get coverage for eight at-home COVID-19 tests a month, the Biden administration announced Thursday. The announcement from the Centers for Medicare and Medicaid Services applies to both beneficiaries in traditional and Medicare Advantage plans. […]
January 31, 2022
Via: medicaldevice-network.comEmpowered Diagnostics is recalling two Covid-19 tests, CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, as they have been distributed with labels incorrectly indicating that they are US Food and Drug Administration (FDA) authorised. The FDA […]
December 29, 2021
Via: medicaldevice-network.comSeveral Korean companies are exporting Covid-19 tests to the US with a rise in Omicron variant of the SARS-CoV-2 virus, Koreanbiomed reported. South Korean firm Humasis entered an agreement with Celltrion to distribute Covid-19 antigen self-test kits worth $43.5m to […]
December 7, 2021
Via: medicaldevice-network.comBioGX has reported that its portfolio of Covid-19 tests that work on the nucleocapsid (N-gene) and envelope (E-gene) can identify the Omicron variant of the SARS-CoV-2 virus. The company’s Covid-19 surveillance programme comprises complete in-silico assessment and investigational testing by […]
October 1, 2021
Via: medicaldevice-network.comQIAGEN has secured a new contract from the US Government to boost production capacity for Covid-19 tests running on NeuMoDx instruments. The $3.4m contract was awarded by the Department of Defense (DoD). Under the contract, QIAGEN will increase production of […]
April 29, 2020
Via: CNBCPresident Donald Trump said he thinks the U.S. will “very soon” be able to test 5 million people a day for the coronavirus – but there’s “no way on Earth” the country can reach that goal, according to the government’s […]
April 14, 2020
Via: medicaldevice-network.comBD has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an additional molecular diagnostic test for Covid-19 that provides results in two to three hours. The test also secured CE Mark in Europe. This […]
April 8, 2020
Via: ForbesThere is a huge demand around the world to understand Covid-19. Those experiencing symptoms need to know if they’re infected, while those recovered need to know if they’re able to return to work. The problem of developing technology that can […]
Innovation, Patient Experience, Regulatory
April 7, 2020
Via: CNBCWalgreens said Tuesday that it plans to open 15 drive-thru testing locations for the coronavirus across seven states, starting later this week. The sites will be in Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas, the drugstore chain said in […]
March 24, 2020
Via: CNBCTwo of the largest private labs in the U.S. will collectively be able to process more than 300,000 COVID-19 tests by the end of the week, their CEOs say. LabCorp CEO Adam Schechter told CNBC’s “Squawk Box” on Tuesday the […]