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 ...

Hologic, Inc. HOLX recently announced the receipt of the FDA’s Emergency Use Authorization (EUA) for its Aptima SARS-CoV-2 assay, which can be used to detect SARS-CoV-2, the virus causing coronavirus.

NEW YORK CITY (WABC) -- It could be a game changer in COVID 19 testing: A company with offices in the Tri-State area received emergency authorization from the FDA for a test that could get results ...

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 ...

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 ...

3EO becomes the first point-of-care molecular technology to be retail priced below $15 per test. 3EO adds a breakthrough business model enabling more physician practices to upgrade technology from ...

The next wave of covid tests take advantage of some really cool molecular biology. They can be run by hospitals and doctors ...

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 ...

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.

Given the highly infectious nature of the COVID pathogen, tests for the virus had to be quick, reliable and safe. The test ...