Cue Health Evaluating Warning Letter Received from Food and Drug Administration (FDA)

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05/13/2024 - 08:30 PM

SAN DIEGO--(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.