Business Wire

Cue Health Receives FDA Emergency Use Authorization for Molecular Mpox Test

SAN DIEGO--(BUSINESS WIRE)--Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company, today announced it has received Emergency Use Authorization (EUA) from the United States Food and Drug ...
Benzinga.com

Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test

Cue Health Inc 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 device ...
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 ...
Healthcare Dive

Cue Health wins first non-emergency authorization for COVID test

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 ...
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 ...
Nasdaq

Cue Health Receives De Novo Authorization From FDA For COVID-19 Molecular Test

(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 ...
Business Wire

Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use

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 ...
Business Insider

Cue Health Receives Emergency Use Authorization For Molecular Test To Detect Mpox

(RTTNews) - Cue Health (HLTH) has received Emergency Use Authorization from the FDA for its molecular test to detect the mpox virus. The nucleic acid amplification test is run on a Cue Reader, and ...