FDA Warns About Counterfeit COVID-19 Tests
Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported to and sold in the US, the agency says. The alert also tells consumers how to spot counterfeit tests.
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The agency says the diagnostics could produce inaccurate results, which may delay proper treatment and further the spread of COVID-19.
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This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR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.