Is cue awaiting any FDA approval

Currently, Cue Health, Inc. is not awaiting any FDA approval for its medical devices or tests. The company has already received an Emergency Use Authorization (EUA) for its Cue COVID-19 Test and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. However, the FDA has recently revoked these EUAs due to concerns about the reliability of the tests in detecting SARS-CoV-2 virus.

1. **FDA Review Status**: The FDA review date for Cue Health's medical devices is not currently available.
2. **Previous FDA Authorizations**: Cue Health did receive an EUA for its COVID-19 test, which was initially authorized for point-of-care use and later for home use. However, these EUAs have been revoked by the FDA.
3. **Recent FDA Actions**: The FDA has issued warnings against using Cue Health's COVID-19 tests due to the risk of false results. The agency has also recommended that users dispose of the tests and retest patients with different FDA-authorized tests if inaccurate results are suspected.

In conclusion, Cue Health is not in the process of seeking FDA approval for any new medical devices or tests. Instead, the company is facing regulatory issues related to the reliability of its existing COVID-19 tests, which have led to the revocation of FDA authorizations and warnings to users.