Search Tag: Emergency Use Authorization

IMAGING Management

FDA Amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay

2020 06 Oct

Hologic, Inc.  announced today that its Aptima® SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. This authorization follows an  announcement  last week... Read more

ICU Management

FDA Grants ExThera’s Seraph-100 Blood Filter Emergency Use Authorization for COVID-19

2020 17 Apr

After promising COVID-19 treatments in Germany, France, Italy, Spain and the USA, ExThera Medical ’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has been granted Emergency Use Authorization by the Food and Drug Administration (FDA). This approval comes soon after first use of the device to treat COVID-19 patients in Europe and in... Read more