FDA Approves Companion Diagnostic For Obesity Drug
The US FDA has given thumbs-up to a genetic test from PreventionGenetics, the first agency-approved class II molecular companion diagnostic that looks for genetic deficiencies associated with obesity.
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Another Class I Recall For Datascope’s Aortic Balloon Pumps
Datascope/Getinge has initiated another recall of its Intra-Aortic Balloon Pumps, this time for a potentially faulty cable connection.
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.