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 ...

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 ...

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

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 classification ...

(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 ...

Check your cabinets. The U.S. Food and Drug Administration (FDA) warned consumers and healthcare professionals Monday that COVID-19 tests from Cue Health may give you false results and should be ...

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 global diagnostics market was valued at approximately $180 billion in 2022 and is projected to grow to over $348 billion by 2030. Some of the key drivers of that growth are molecular diagnostics ...

(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.

(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 ...

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 ...