Cue Health De Novo Authorization From FDA For COVID-19 Home Use Test
Portfolio Pulse from Charles Gross
Cue Health (NASDAQ:HLTH) has received De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for home and point-of-care use. This marks the first FDA De Novo authorization for a home use COVID-19 test and the first for any home use respiratory test.
June 06, 2023 | 7:54 pm
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Cue Health receives FDA De Novo authorization for its Cue COVID-19 Molecular Test, marking a significant industry breakthrough.
Cue Health's FDA De Novo authorization for its COVID-19 Molecular Test is a significant industry breakthrough. This authorization sets a new standard for home use COVID-19 tests and home use respiratory tests, which could lead to increased demand for Cue Health's products and services. As a result, this news is likely to have a positive short-term impact on the company's stock price.
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IMPORTANCE 90
RELEVANCE 100