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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Seeking Alpha

FDA approves Cue Health's at-home COVID-19 test

The U.S. Food and Drug Administration (FDA) on Tuesday said it had approved Cue Health's (NASDAQ:HLTH) at-home COVID-19 test, the first ever to be granted authorization through a traditional premarket ...