News We’re Watching: Skipjack Medical Recall; $42M Verdict In Boston Sci Patent Battle; Nanoparticle Engineering Group Launched
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.
You may also be interested in...
Skip Skippack COVID-19 Test, FDA Warns
The Food and Drug Administration has designated the recall of a COVID-19 test from SML Distribution LLC as class I, the US agency’s most serious classification.
News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.
FDA Clears Diagnostic Aimed At Reducing STDs In Women
The US Food and Drug Administration has granted 510(k) clearance to Visby Medical for its product designed to diagnose three of the most common sexually transmitted infections in women.