Rheonix Seeks Emergency Authorization for COVID-19 Test March 20, 2020 The cartridge-based system reduces sample handling time. Read More
Carbon Health Ships Home COVID-19 Tests to California Patients March 20, 2020 The kits should reduce the strain on clinics and prevent non-infected individuals from exposing themselves to the virus, the company said. 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
FDA Suspends Domestic Inspections as Coronavirus Outbreak Spreads March 19, 2020 All eligible FDA employees are now teleworking. 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
Emergent BioSolutions to Develop Two COVID-19 Treatments March 19, 2020 COVID-EIG will use plasma of immunized horses with antibodies to the virus as a potential treatment for severe hospitalized patients. 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
FDA Clears Two More Coronavirus Diagnostics for Emergency Use March 17, 2020 More than 90 diagnostic developers have contacted the FDA seeking guidance on coronavirus test development and validation, the agency said. Read More
European Commission to Fund Diagnostics Research to Tackle COVID-19 March 16, 2020 “As cases continue to rise, public health is the number one priority,” said the commission’s President Ursula von der Leyen. Read More
FDA Gives Go-Ahead for New York to Begin Testing for Coronavirus March 13, 2020 Labs authorized by NYSDOH, “will not engage with FDA to begin patient testing,” said FDA Commissioner Stephen Hahn. Read More
Roche Gets Emergency Use Authorization for COVID-19 Test March 13, 2020 The diagnostic test is the first commercial product to receive emergency authorization during the outbreak. Read More
MedTech Europe Issues Update on COVID-19 March 12, 2020 The group is urging industry to continue to develop and make available needed protective equipment. Read More
RSS
