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 ...
Nasdaq

Cue Health Launches Cue Care™ Nationwide to Provide Same-Day, At-Home, Test-to-Treatment Service for COVID-19

Consult virtually and on-demand with a healthcare professional about their test result; Obtain an e-prescription - if medically indicated - for a medication to treat the virus; and Get the medication ...
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 ...
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 ...
Benzinga.com

Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test

Cue Health Inc (NASDAQ:HLTH) 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 ...
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 ...
STAT

Cue Health, Covid-19 testing company, is shutting down

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to ...
Homeland Security Today

FDA Permits Marketing of First COVID-19 at-Home Test Using Traditional Premarket Review Process

The U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect ...
Business Wire

Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use

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 ...
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 ...