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The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S.
The FDA approved a molecular test for emergency use and a supplemental new drug application for a blood sugar medication.
Authorized for use in professional point-of-care settings, the nucleic acid amplification diagnostic tool delivers results in 25 minutes.
The nucleic acid amplification test returns results in 25 minutes and is authorized for use in professional point-of-care settings.
With the emergence of Coronavirus infection called COVID-19, testing is essential for containment and mitigation purposes. In a pandemic, control is essential to limit the spread of any virus. Initially, contact tracing was not available which ultimately led to the 2020 pandemic. However, with the development of COVID-19 rapid testing, the rate of infections has lessened and has allowed for some return to normalcy. In this review, we discuss the various antibody, antigens, and molecular tests that have been given emergency authorization (EA) from the Food and Drug Administration (FDA). Moreov...