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138 articles found
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Coronavirus (COVID-19) Update: April 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i... -
Coronavirus (COVID-19) Update: April 13, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As the FDA celebrates National Minority Health Month, we’re wo...
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FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon CancerToday, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting...
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Coronavirus (COVID-19) Update: April 9, 2021The U.S. Food and Drug Administration (FDA), today, announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA issued a letter to health care personnel and f...
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Coronavirus (COVID-19) Update: April 6, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA issued an Emergency Use Authorization (EUA) to Symbiot...
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Coronavirus (COVID-19) Update: April 2, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Following recent FDA actions to support test development, the...
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Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test DevelopmentFollowing recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Toda...
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Coronavirus (COVID-19) Update: March 30, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The agency has updated its FDA COVID-19 Response At-A-Glance S...
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FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care SettingsToday, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent...
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Coronavirus (COVID-19) Update: March 26, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 23, 2021, the FDA issued an emergency use authorizati...