Cue Health Evaluating Warning Letter Received from Food and Drug Administration (FDA)
13 Mayo 2024 - 7:30PM
Business Wire
Cue Health Inc. (Nasdaq: HLTH), a healthcare technology company
(the “Company”), has received a warning letter from the FDA about
its Emergency Use Authorized (EUA) COVID-19 test. The Company is
currently evaluating the letter and determining its response, with
more information to follow in the next few days.
About Cue
Cue Health Inc. (Nasdaq: HLTH) is a healthcare technology
company that empowers healthcare providers to streamline their
ability to deliver value-based care with fast, highly accurate test
results on demand. Cue received De Novo authorization from the U.S.
Food and Drug Administration (FDA) for its COVID-19 test, which
became the first home use respiratory test to receive this FDA
approval. Cue also received Emergency Use Authorization from the
FDA for its molecular Mpox test at the point-of-care. Cue, founded
in 2010, holds over 100 patents and is headquartered in San Diego.
For more information, please visit www.cuehealth.com.
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