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 ...
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 ...
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 ...
Reuters

Cue Health awarded $481 mln to scale up production of COVID-19 test -HHS

Oct 13 (Reuters) - The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and ...
Becker's Hospital Review

Cue Health’s rapid, portable COVID-19 test gets FDA emergency use authorization

The FDA granted emergency use authorization June 12 to healthcare tech company Cue Heath’s rapid COVID-19 test. The single-use molecular test identifies the RNA of the virus that causes COVID-19 from ...