Yahoo Finance

FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration categorized Cue Health’s ...
Yahoo Finance

FDA warns users not to use Cue Health’s at-home Covid-19 tests

The US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid-19 tests, just one week after the agency issued a warning letter saying that Cue was not following the ...
MobiHealthNews

Cue Health receives first-ever de novo authorization for at-home COVID-19 test

Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test. The Cue COVID-19 Molecular Test detects ...