News We’re Watching: Skippack Medical Recall; $42M Verdict In Boston Sci Patent Battle; Nanoparticle Engineering Group Launched
Executive Summary
Three diagnostics that detect COVID-19 as well as the flu got regulatory authorization this week. Meanwhile, Skipjack’s COVID-19 test recall was designated class I; a new collaboration to promote nanoparticle engineering was launched; and an FDA guidance document discusses long-term safety for products used in newborns.
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FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.