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 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 ...
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--(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 ...
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 ...
The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter ...
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 ...
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