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 ...
Nasdaq

This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test

The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter ...
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 ...
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 ...
EurekAlert!

AI model proactively predicts if a COVID-19 test might be positive or not

COVID-19 and its latest Omicron strains continue to cause infections across the country as well as globally. Serology (blood) and molecular tests are the two most commonly used methods for rapid COVID ...
Becker's Hospital Review

NBA’s rapid COVID-19 test getting a tryout in 5 states

HHS has launched a pilot program in five states to test the portable COVID-19 molecular test used by the NBA to control the virus in its “bubble” this season. The pilot will determine how to integrate ...
Time

Is It Flu, COVID-19, or RSV? How to Navigate the New World of At-Home Testing

Before COVID-19, figuring out whether a sore throat, fever, and runny nose were caused by a cold, flu, or strep wasn’t a top priority. You either powered through, knowing you’d be miserable for a few ...
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

Minute Molecular’s DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization

EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...
KTVU

Study: Delta’s pre-flight COVID-19 tests significantly decrease risk of infection

NEW YORK - As more people pack their bags to travel, a new study found that the risk of exposure to COVID-19 while on a Delta flight decreased significantly due the airline’s pre-flight testing for ...
Science Daily

AI model proactively predicts if a COVID-19 test might be positive or not

A new study shows machine-learning models trained using simple symptoms, demographic features are effective in predicting COVID-19 infections. COVID-19 and its latest Omicron strains continue to cause ...