Cue Sample Wand News Today

The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S.

The FDA approved a molecular test for emergency use and a supplemental new drug application for a blood sugar medication.

Authorized for use in professional point-of-care settings, the nucleic acid amplification diagnostic tool delivers results in 25 minutes.

The nucleic acid amplification test returns results in 25 minutes and is authorized for use in professional point-of-care settings. 

With the emergence of Coronavirus infection called COVID-19, testing is essential for containment and mitigation purposes. In a pandemic, control is essential to limit the spread of any virus. Initially, contact tracing was not available which ultimately led to the 2020 pandemic. However, with the development of COVID-19 rapid testing, the rate of infections has lessened and has allowed for some return to normalcy. In this review, we discuss the various antibody, antigens, and molecular tests t...

Share this article Share this article SAN DIEGO, April 5, 2021 /PRNewswire/ -- Cue Health Inc. ("Cue"), a healthcare technology company, today announced "Cue for Schools," a COVID-19 on-site testing solution for K-12 schools and universities that uses the Cue Health Monitoring System and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the nations first molecular diagnostic test available without a prescription with Emergency Use Authorization (EUA) from the U.S. Food and Drug Ad...

The system delivers its results to a companion app in about 20 minutes, according to the agency.

Share this article Share this article SILVER SPRING, Md., March 5, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.  "The ...

Share this article Share this article SAN DIEGO, March 5, 2021 /PRNewswire/ -- Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter sale of its fast, accurate, COVID-19 test, making it the nations first molecular diagnostic test available to consumers without a prescription. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nas...

Share this article Share this article SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Cue Health Inc. (Cue), a healthcare technology company, today announced its molecular point-of-care COVID-19 Test has received the CE mark, clearing it for sale and distribution in the European Union (EU). The Cue COVID-19 Test is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the Cue Health Monitoring System, displaying test results directly on a connected mobile smart device in...