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Omicron Variant: COVID Molecular Tests That May Be Impacted
Dec 28 – The performance of certain EUA-authorized molecular tests may be impacted by mutations in the omicron variant.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreDec 28 – The performance of certain EUA-authorized molecular tests may be impacted by mutations in the omicron variant.
Nov 15 – FDA updates test policies to help ensure accuracy & reliability of tests, increase access to at-home tests.
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Dec 21 – An IVC filter is a small cage-like device inserted into the interior vena cava (IVC) to capture blood clots.
Nov 16 – FDA authorized marketing of EaseVRx to help with pain reduction in adults with chronic lower back pain.
Nov 12 – Update provides additional info on the recall of ventilators, BiPAP, CPAP machines, recommendations for users.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.