FDA issues an EUA for the Cue COVID-19 Test for Home and OTC Use, a molecular nucleic acid amplification test and the first molecular test…
Posts published in “FDA News Alerts”
Coronavirus (COVID-19) Update: March 5, 2021 Original source: http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-march-5-2021
The U.S. Food and Drug Administration issued an emergency use authorization for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is…
A dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any articles of…
FDA alerted users of thermal imaging systems intended to measure body temperature that improper use of the systems may provide inaccurate temperature readings. FDA also…
The FDA is alerting consumers, health care providers and users that improper use of thermal imaging devices may provide inaccurate temperature readings. Original source: http://www.fda.gov/medical-devices/safety-communications/improper-use-thermal-imaging-devices-fda-safety-communication
Coronavirus (COVID-19) Update: March 2, 2021 Original source: http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-march-2-2021
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test. Original source: http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-authorization-quidel-quickvue-home-covid-19-test
FDA authorizes marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. Original source:…
The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to…