Cue Health Covid Test Approval

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Cue Health's Covid-19 tests lead to false results, FDA warns - STAT

(9 days ago) WEBT he Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA warning letter to the …

https://www.statnews.com/2024/05/13/cue-health-covid-19-test-fda-warning-false-positives/

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Cue Health Makes De Novo Submission to FDA for Full Clearance …

(8 days ago) WEBA prior submission to the FDA for Emergency Use Authorization of Cue's COVID-19 at-home, over-the-counter test showed 98.9% accuracy. An independent …

https://www.prnewswire.com/news-releases/cue-health-makes-de-novo-submission-to-fda-for-full-clearance-of-its-molecular-covid-19-test-301536865.html

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FDA Authorizes Cue Health's COVID-19 Test for At …

(3 days ago) WEBThe Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nasal swab and delivers results in about 20 minutes to the user's mobile smart device. The Cue OTC Test …

https://www.prnewswire.com/news-releases/fda-authorizes-cue-healths-covid-19-test-for-at-home-and-over-the-counter-use-301241725.html

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FDA approves Cue Health's at-home COVID test Reuters

(8 days ago) WEBThe U.S. Food and Drug Administration on Tuesday approved Cue Health's at-home COVID-19 test, the first coronavirus test to get marketing authorization using a traditional premarket review, the

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-cue-healths-at-home-covid-test-2023-06-06/

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Cue Health wins first non-emergency authorization for COVID test, …

(1 days ago) WEBDive Brief: The U.S. Food and Drug Administration has granted de novo clearance to the Cue COVID-19 Molecular Test, the first at-home, over-the-counter test …

https://www.medtechdive.com/news/Cue-COVID-19-Test-Approval-FDA/652374/

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Cue Health Makes - Business Wire

(4 days ago) WEBCue's COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription, which is currently under De …

https://www.businesswire.com/news/home/20230509005361/en/Cue-Health-Makes-De-Novo-Submission-to-FDA-for-Full-Clearance-of-its-Cue%C2%AE-RSV-Molecular-Test

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Cue Health Launches Cue Care™ Nationwide to …

(2 days ago) WEBCue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision.

https://www.prnewswire.com/news-releases/cue-health-launches-cue-care-nationwide-to-provide-same-day-at-home-test-to-treatment-service-for-covid-19-301613695.html

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US FDA approves Cue Health's at-home COVID test - Yahoo News

(5 days ago) WEBThe FDA had granted emergency use authorization for the test in 2021 to make it available to consumers without a prescription. The agency's approval for the …

https://news.yahoo.com/us-fda-approves-cue-healths-193154428.html

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Cue Health Makes De Novo Submission to FDA for Full Clearance …

(8 days ago) WEBCue's COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription, which is currently under De …

https://finance.yahoo.com/news/cue-health-makes-novo-submission-131500962.html

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Cue Health receives first-ever de novo authorization for at-home …

(4 days ago) WEBThe Cue COVID-19 Molecular Test detects genetic material from the SARS-CoV-2 virus. It consists of a nasal swab, or Cue Sample Wand, and a Cue Cartridge …

https://www.mobihealthnews.com/news/cue-health-receives-first-ever-de-novo-authorization-home-covid-test

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FDA tells users to throw away Cue Health’s home COVID tests

(9 days ago) WEBFDA chides Cue Health for changing its home COVID test, tells consumers to throw them out. Earlier this month, the company disclosed in an SEC filing the latest in a …

https://www.fiercebiotech.com/medtech/fda-chides-cue-health-changing-its-home-covid-test-tells-consumers-throw-them-out

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FDA warns about using over-the-counter COVID-19 tests from …

(Just Now) WEBThe FDA first authorized the Cue Health COVID-19 Test in June 2020, "granted revisions to the authorized labeling on Aug. 20, 2020, and subsequently …

https://www.msn.com/en-us/health/other/fda-warns-about-using-over-the-counter-covid-19-tests-from-cue-health/ar-BB1mktl5

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FDA warns users not to use Cue Health’s at-home Covid-19 tests

(9 days ago) WEBThe Cue Health Covid-19 test for home and over-the-counter use was authorised by the FDA for point-of-care testing in June 2020, receiving an emergency …

https://finance.yahoo.com/news/fda-warns-users-not-cue-105158696.html

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Cue COVID-19 Test for Home and Over The Counter (OTC) …

(1 days ago) WEBThe Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior …

https://www.fda.gov/media/146468/download

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The FDA says you can’t trust COVID-19 tests from Cue Health

(9 days ago) WEBThe COVID-19 Test The FDA Now Says You Can't Trust. San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo …

https://www.slashgear.com/1581698/covid-19-test-false-results-according-to-fda/

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Cue Health Receives FDA Warning Letter Regarding Emergency …

(9 days ago) WEB(RTTNews) - Cue Health Inc. (HLTH) said it has received a warning letter from the U.S. Food and Drug Administration or FDA about its Emergency Use …

https://www.nasdaq.com/articles/cue-health-receives-fda-warning-letter-regarding-emergency-use-authorized-covid-19-test

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FDA advises against using Cue Health COVID-19 tests, sends …

(5 days ago) WEBThe Food and Drug Administration said Monday not to use Cue Health’s COVID-19 tests because of an increased risk of false results. FDA inspectors found Cue …

https://www.medtechdive.com/news/fda-cue-health-covid-19-tests-warning-letter/715998/

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Cue Health Applies with FDA for Emergency Use Authorization of …

(5 days ago) WEBCue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription …

https://www.prnewswire.com/news-releases/cue-health-applies-with-fda-for-emergency-use-authorization-of-its-cue-flu--covid-19-molecular-test-301639461.html

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FDA warns not to use Cue Health COVID-19 test kits

(3 days ago) WEBThe Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health] The FDA has warned that home test users, caregivers and healthcare providers …

https://www.massdevice.com/fda-warns-cue-health-covid-19-tests/

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Cue Health Must Cease Sale, Marketing of COVID-19 Tests …

(5 days ago) WEBMay 14, 2024. Devices Regulatory Affairs. Cue Health must immediately stop sale and distribution of its COVID-19 tests and consumers should throw away any …

https://www.fdanews.com/articles/213673-cue-health-must-cease-sale-marketing-of-covid-19-tests-following-inspection

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How To Get Tested For COVID-19 In New Jersey

(6 days ago) WEBLearn how to get tested for COVID-19 in New Jersey. Skip to content. Official Site of the State Of New Jersey. Return to nj.gov. New Jersey. COVID-19 Information Hub. Call

https://covid19.nj.gov/pages/testing

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Melinda French Gates resigns from Gates Foundation - STAT

(2 days ago) WEBCue Health’s Covid-19 tests could give false results, FDA… Cue Health’s Covid-19 tests could give false results, FDA warns CDC launching wastewater …

https://www.statnews.com/2024/05/13/melinda-french-gates-resigns-gates-foundation/

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COVID-19 Diagnostic Testing AFC Urgent Care North Bergen

(8 days ago) WEBIf you are exhibiting symptoms of COVID-19, schedule a telemedicine appointment with AFC Urgent Care North Bergen today. Telemedicine visits are accepted seven days a …

https://www.afcurgentcare.com/north-bergen/patient-services/covid-19-diagnostic-testing/

Category:  Medicine Show Health

Walk In MinuteClinic Locations in New Jersey - CVS

(1 days ago) WEBMinuteClinic now offers two options for affordable video-based care treating adults and children over age 2, right in your home. Our E-clinic visits require insurance and allow …

https://www.cvs.com/minuteclinic/clinic-locator/nj/

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