Cepheid Nabs First FDA Authorization For Rapid-Response COVID-19 Test
Point-of-care test can give results in 45 minutes
A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.
You may also be interested in...
A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.
The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.
News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope
This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.