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

Rhea-AI Summary

Cue Health (Nasdaq: HLTH) has received a warning letter from the FDA regarding its Emergency Use Authorized (EUA) COVID-19 test. The healthcare technology company is currently evaluating the letter and determining an appropriate response. Further details will be provided in the coming days.

Positive

• The company is taking immediate action to evaluate the FDA's warning letter.
• Cue Health's proactive approach may help mitigate potential long-term impacts.

Negative

• Received a warning letter from the FDA about its EUA COVID-19 test.
• Potential risks to the company's reputation and product credibility.
• Possible impact on stock prices due to regulatory scrutiny.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240513451572/en/

Investor Relations

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Press

Cue Health

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Source: Cue Health Inc.

FAQ

What recent update has Cue Health (HLTH) provided?

Cue Health recently received a warning letter from the FDA concerning its EUA COVID-19 test.

What is Cue Health's plan regarding the FDA warning letter?

Cue Health is currently evaluating the FDA's warning letter and determining its response.

How might the FDA warning letter affect Cue Health's stock?

The FDA warning letter could impact Cue Health's stock prices due to potential regulatory scrutiny.

When will Cue Health provide more information about the FDA's warning letter?

Cue Health stated that more information will be provided in the next few days.

What is the subject of the FDA warning letter received by Cue Health?

The warning letter concerns Cue Health's Emergency Use Authorized (EUA) COVID-19 test.