The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results. Early in the ...

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 ...

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 ...

There's still a lot of confusion around the best time to take a COVID test and where to get them. Here, experts share their ...

Beginning November 15th, Consumers Can Get Cue's Fast and Accurate COVID-19 Tests, 24/7 Virtual Care, E-Prescription Services, and CDC-Compliant Test Results for Travel: Anywhere, Anytime SAN DIEGO, ...

The U.S. Food and Drug Administration on Tuesday approved Cue Health's at-home COVID-19 test, the first coronavirus test to get marketing authorization using a traditional premarket review, the agency ...

San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo authorization from the U.S. Food and Drug Administration (FDA) for its at-home COVID-19 test kit.

The FDA has extended the shelf life for some COVID-19 tests. Now that allergy season is here, many are finding themselves with symptoms asking: Is it allergies or a cold? COVID? Something else? Since ...

An inspection revealed Cue Health made changes to the tests that reduce their reliability to detect SARS-CoV-2 virus. The Food and Drug Administration (FDA) has issued a warning letter to Cue Health ...

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 ...