Cue Health Fda Authorization

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Cue Health Applies with FDA for Emergency Use Authorization of …

(8 days ago) WEBSAN DIEGO, CA, October 4, 2022 — Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company that puts diagnostic information at the center of care, today …

https://cuehealth.com/about/press/cue-health-applies-with-fda-for-emergency-use-authorization-of-its-cue-flu

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Cue Health Achieves Groundbreaking Milestone with FDA: First …

(9 days ago) WEBThis significant achievement highlights Cue Health's dedication to empowering individuals with accurate, accessible, and actionable diagnostic tools. The …

https://investors.cuehealth.com/news-releases/news-release-details/cue-health-achieves-groundbreaking-milestone-fda-first-company

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Cue Health Receives FDA Emergency Use Authorization for Its …

(8 days ago) WEBCurrently, Cue Health's products authorized for commercial sale in the United States are the Cue COVID-19 Test Kit and the Cue Mpox Molecular Test Kit, …

https://investors.cuehealth.com/news-releases/news-release-details/cue-health-receives-fda-emergency-use-authorization-its-rapid

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

(2 days ago) WEBOutside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, regulatory approval …

https://cuehealth.com/about/press/cue-health-makes-de-novo-submission-to-fda-for-full-clearance-of-its

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

(Just Now) WEBSan Diego, CA (March 5, 2021) - – Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. …

https://cuehealth.com/about/press/fda-authorizes-cue-health's-covid-19-test-for-at-home-and-over-the

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Cue Health Achieves Groundbreaking Milestone with …

(Just Now) WEBSAN DIEGO, June 06, 2023--Cue Health (Nasdaq: HLTH), a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food

https://finance.yahoo.com/news/cue-health-achieves-groundbreaking-milestone-194900543.html

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Coronavirus (COVID-19) Update: FDA Issues Authorization for First

(7 days ago) WEBEspañol. 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 …

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-authorization-first-molecular-non-prescription-home-test

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Cue Health Receives FDA Emergency Use Authorization for Its …

(9 days ago) WEBCue Health Inc. (“Cue”), a healthcare technology company, announced today that it has received Emergency Use Authorization (“EUA”) from the U.S. Food …

https://finance.yahoo.com/news/cue-health-receives-fda-emergency-120010060.html

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Cue Health Receives FDA Emergency Use Authorization for …

(2 days ago) WEBThis EUA marks an important milestone for Cue Health, as it is the company’s first non-COVID test to receive FDA authorization, as well as its initial …

https://www.businesswire.com/news/home/20230320005260/en/Cue-Health-Receives-FDA-Emergency-Use-Authorization-for-Molecular-Mpox-Test

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

(1 days ago) WEB1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to …

https://www.fda.gov/media/146467/download

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

(3 days ago) WEBSAN DIEGO, March 5, 2021 /PRNewswire/ -- Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) …

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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Cue Health Becomes First Company to Receive FDA De Novo …

(8 days ago) WEBCue Health Inc (NASDAQ: HLTH) became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for …

https://finance.yahoo.com/news/cue-health-becomes-first-company-145411289.html

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

(5 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://investors.cuehealth.com/news-releases/news-release-details/cue-health-makes-de-novo-submission-fda-full-clearance-its

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Cue Health Applies with FDA for Emergency Use Authorization of …

(9 days ago) WEBSAN DIEGO, CA, October 4, 2022 — Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company that puts diagnostic information at the center of care, today …

https://investors.cuehealth.com/news-releases/news-release-details/cue-health-applies-fda-emergency-use-authorization-its-cue-flu

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FDA Permits Marketing of First COVID-19 At-Home Test Using …

(1 days ago) WEBEspañol. Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic …

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process

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

(1 days ago) WEBThe Cue COVID-19 Test Cartridge will heat up inside the Cartridge Reader for one minute. Insert the Cue Sample Wand with the nasal sample when the Cue Health App screen …

https://www.fda.gov/media/146470/download

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COVID-19 Cue™ COVID-19 Test Instructions For Use For …

(1 days ago) WEBUse with the Emergency Use Authorization Only Cue Health Monitoring System and Cue Health Mobile Application The Cue COVID-19 Test is only for use under the Food …

https://www.fda.gov/media/138826/download

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A New Use for Wegovy Opens the Door to Medicare Coverage for …

(4 days ago) WEBThe FDA recently approved a new use for Wegovy, the blockbuster anti-obesity drug, to reduce the risk of heart attacks and stroke in people with cardiovascular …

https://www.kff.org/medicare/issue-brief/a-new-use-for-wegovy-opens-the-door-to-medicare-coverage-for-millions-of-people-with-obesity/

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