
First Molecular Non-Prescription, At-Home Test for COVID-19
New EUA for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use; for use in adults or children age 2 or older.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreNew EUA for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use; for use in adults or children age 2 or older.
New EUA for the Quidel QuickVue At-Home COVID-19 Test; individuals can rapidly collect and test their sample at home.
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Mar 1 - New surgical device provides a minimally invasive gynecologic surgical option for non-cancerous conditions.
Feb 26 - The FDA authorized marketing of a non-invasive medical device that athletes can wear when playing sports.
Feb 17 - The FDA approved a 3D-printed implant, made for each patient individually, to replace the talus bone in the ankle.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.