FDA Grants First De Novo Authorization for COVID-19 Home Use Test
Cue Health has received De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.
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Search Results for: covid-19
FDA Issues Class I Recall for COVID-19 At-Home Tests
This Class I recall is for certain COVID-19 at-home test kits containing liquid solution that may be contaminated with bacteria.
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Cancer Screening Delays Due to COVID-19 Fuel Rise in Diagnoses
Delays in cancer screening during the COVID-19 pandemic will likely cause a significant increase in cancer cases.
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Affordable At-Home Molecular Test for COVID-19, Flu-A, Flu-B & RSV Moving Closer
The award through the NIH’s RADx Tech program, will support Domus Diagnostics’ at-home molecular test for clinical trial readiness.
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Two COVID-19 Serology Tests Get De Novo Marketing Nod
The U.S. Food and Drug Administration (FDA) granted marketing authorization to two COVID-19 serology tests.
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