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COVID-19 Test EUAs: Independent Assessment of FDA’s Response
Oct 12 - The FDA released an independent assessment of the COVID-19 Emergency Use Authorization (EUA) response.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreOct 12 - The FDA released an independent assessment of the COVID-19 Emergency Use Authorization (EUA) response.
Oct 5 – Certain lots of the Ellume COVID-19 Home Test with the potential for false positive results were recalled.
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Find out how the FDA helps ensure that medical devices are safe from cyber threats and how you can keep devices cybersafe.
Sep 30 - The FDA cleared Siemens NAEOTOM Alpha, a major technological improvement for Computed Tomography (CT) imaging.
Sep 21 - The FDA authorized Paige Prostate, artificial intelligence (AI)-based software for analyzing biopsy images.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.