Search Tag: Food and Drug Administration

ICU Management

New Laboratory Blood Glucose Reference Analyzer from Nova Biomedical

2020 07 Nov

Nova Biomedical announces the availability of Nova Primary, a rapid, accurate, easy to use, blood glucose laboratory analyzer. Nova Primary fills the need for a new glucose reference analyzer to replace the YSI STAT PLUS 2300 Glucose and L-Lactate analyzer (YSI, Inc., Yellow Springs, OH). Manufacturers of blood glucose measuring devices and clinical... Read more

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

ICU Management

Novalung System Receives US FDA Clearance

2020 26 Feb

The US FDA (Food and Drug Administration) has granted 510(k) approval to Fresenius Medical Care North America and Xenios, a Fresenius Medical Care company, for long-term use of its Novalung system for patients with acute lung failure or acute cardiopulmonary failure. The FDA announced this on Friday evening. With class II approval, the Novalung... Read more