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...
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...
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...
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...
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,...
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...
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