May 18, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC)...
May 17, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) authorized ImmunityBio Phase I clinical study for patients with metastatic or locally advanced solid tumors. The study will assess the safety and efficacy of ImmunityBio’s IL-15 superagonist Anktiva (N-803) in...
May 14, 2021 | News, Regulatory
BD (Becton, Dickinson, and Company) announced today the first self-collection, at-home HPV screening has been CE marked to the IVD directive 98/79/EC. With this new claim, diagnostic labs will now be able to process the self-collected vaginal samples using the BD...
May 13, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction...
May 12, 2021 | News, Regulatory
Eyepic Eye Care announced a revolutionary service using the only FDA-approved MiSight multifocal contact lenses meant to slow myopia progression in children. Myopia, which is a refractive eye condition causing nearsightedness, affects approximately 40% of Americans...
