FDA Grants Emergency Use Authorization for bioMérieux’s COVID-19 Test March 25, 2020 The test detects the virus from a nasal swab in approximately 45 minutes. Read More
DiaCarta Earns CE Mark for Coronavirus Test March 24, 2020 The assay targets three SARS-CoV-2 genes to ensure a high degree of sensitivity and accuracy. Read More
Creo Medical Receives FDA Clearance for Hemostasis Device March 23, 2020 Creo’s CROMA platform enables precise endoscopic surgery with miniature endoscopic instruments that cut, coagulate and ablate soft tissue. Read More
FDA Clears Cepheid’s On-Demand Coronavirus Test for Emergency Use March 23, 2020 The test expands the availability of testing and rapid results. Read More
Lucence Working on Coronavirus Sample Collection Device March 20, 2020 Ideally, samples should be transported in a chilled medium, but this is not always possible. Read More
Rheonix Seeks Emergency Authorization for COVID-19 Test March 20, 2020 The cartridge-based system reduces sample handling time. Read More
EchoNous Earns CE Mark for Cardiothoracic Assessment Device March 20, 2020 The company said it will seek additional clearance for more algorithms. Read More
Qiagen Snags CE Mark for Coronavirus Diagnostic March 19, 2020 The multiplex nucleic acid test is the first syndromic testing solution cleared in the EU, the company said. Read More
Abbott’s Coronavirus Test Earns Emergency Clearance March 19, 2020 Abbott will distribute 150,000 tests immediately and aims to provide up to one million tests per week. Read More
Becton Dickinson, BioGX Seek FDA Emergency Clearance for COVID-19 Tests March 18, 2020 The tests would increase the potential capacity to screen for COVID-19 by thousands of tests per day, BD said. Read More
Canon Medical’s Imaging AI Technology Cleared March 18, 2020 The technology distinguishes between the true signal and noise to reconstruct images. Read More
FDA Clears Behold.ai’s Collapsed Lung Radiology Algorithm March 18, 2020 Behold.ai expects to launch the product in the U.S. later in the year. Read More