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 ...

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 ...

The FDA is recommending that anyone who still has any home COVID tests left from Cue Health should throw them away. According to the agency, its inspectors discovered that the diagnostics company had ...

Two years after its cartridge-based diagnostic became the first COVID-19 test given emergency use authorization by the FDA for non-prescription, at-home use, Cue Health has now scored the agency’s ...

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.

Cue Health, the once high-flying San Diego biotech supplying rapid COVID-19 test kits to the NBA and Google, is laying off all employees and shutting down on Friday. Cue’s closure comes a week after ...

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 ...

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 ...