Industry-First At-Home HPV Screening Has Been CE Marked
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...
FDA Grants IDE to ZOLL Medical for ISO Shock Study
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...
New Contact Lenses for Children to Slow Myopia Progression
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...
Pfizer & BioNTech COVID-19 Vaccine Receives EUA for Young Teens
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine to now include young teens between 12 and 15 years of age. Previously, the EUA was approved for patients 16 years of age and older,...
FDA Clears ConforMIS, Inc.’s Knee Replacement System
The U.S. Food and Drug Administration (FDA) has granted ConforMIS Inc. 510(k) clearance for its Identity Imprint™ Knee Replacement System. Available in both posterior stabilized (PS) and cruciate retaining (CR) versions, the system expands the range of options for...
NMPA Approves PARP Inhibitor Pamiparib of BeiGene
China's regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene's PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third for...