Transitioning COVID-19 tests from emergency use authorization to the traditional pre-market pathway has long been a goal for the FDA. “Today’s authorization is the first at-home COVID-19 test granted ...

Cue Health Inc (NASDAQ:HLTH) became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. The de novo is a ...

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 ...

(RTTNews) - Cue Health (HLTH), has receive De Novo authorization from the U.S. Food and Drug Administration for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. This is ...

SAN DIEGO, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Cue Health Inc. (Cue) announced today that, as of November 9, the U.S. Department of Health and Human Services (HHS) began deploying its molecular, ...

SAN DIEGO--(BUSINESS WIRE)--Cue Health (Nasdaq: HLTH), a healthcare technology company, today announced that it has been awarded a new approximately $28 million contract by the Biomedical Advanced ...

SAN DIEGO, Sept. 1, 2022 /PRNewswire/ -- Cue Health (HLTH) ("Cue") (Nasdaq: HLTH) today announced that it has made a de novo submission to the U.S. Food and Drug Administration (FDA) for full ...

If you buy something from a Verge link, Vox Media may earn a commission. See our ethics statement. is a senior reporter and author of the Optimizer newsletter. She has more than 13 years of experience ...

This significant achievement highlights Cue Health's dedication to empowering individuals with accurate, accessible, and actionable diagnostic tools. The FDA's De Novo authorization signifies that the ...

SAN DIEGO--(BUSINESS WIRE)--Cue Health (Nasdaq: HLTH), a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and ...