STAT

Cue Health, Covid-19 testing company, is shutting down

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to ...
San Diego Union-Tribune

San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out.

The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results. Early in 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 ...
WRIC

Throw out COVID-19 tests made by Cue Health, FDA warns

SAN DIEGO (KSWB/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a California-based health care company. Cue Health, headquartered in ...
Seeking Alpha

FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

SILVER SPRING, Md., June 6, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic ...
MobiHealthNews

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home. Developed by Cue Health, the Cue ...
Benzinga.com

STAT+: Cue Health, Covid-19 testing company, is shutting down

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to ...