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 ...

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 ...

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 ...

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 ...

A PCR test detects the actual genetic material of the virus and involves a step that amplifies the presence of any material ...

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.

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 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 ...