MobiHealthNews

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

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 ...
Healthcare Dive

Cue Health wins first non-emergency authorization for COVID test

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 ...
FierceBiotech

FDA chides Cue Health for changing its home COVID test, tells consumers to throw them out

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 ...
San Diego Union-Tribune

San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out.

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 ...
Yahoo

FDA: Cue Health COVID tests may return false positive, negative results, so throw them away

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 ...
FierceBiotech

Cue Health racks up FDA's first de novo nod for an at-home COVID test

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 ...
San Diego Union-Tribune

San Diego COVID-19 test maker Cue Health – once worth $2.3B – lays off entire company and shuts down

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 ...
MobiHealthNews

Cue Health receives first-ever de novo authorization for at-home COVID-19 test

Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test. The Cue COVID-19 Molecular Test detects ...
SlashGear

The COVID-19 Test The FDA Now Says You Can't Trust

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.
MD&M East

Cue the End Credits for This COVID-19 Test Maker

After years of financial struggle post-COVID-19’s diagnostic boom, Cue Health seems to have begrudgingly hung the white flag of defeat, announcing recently that it would shut down operations and lay ...
Business Wire

Cue Health Collaborates with Pfizer to Provide People who Test Positive for COVID-19 with Actionable Health Information to Better Inform their Treatment Journey

SAN DIEGO--(BUSINESS WIRE)--Cue Health (“Cue”) (Nasdaq: HLTH), the healthcare technology leader in at-home and point-of-care diagnostic innovations, today announced a new collaboration with Pfizer Inc ...