Category Diagnostics
First Rapid Corona Antigen Test Approved for Clinical Study in Germany
The health tech company Digital Diagnostics AG from Mainz, Germany, has received approval for clinical trials from a German ethics committee and the Federal Institute for Drugs and Medical Devices (BfArM). This is a crucial regulatory step in the ongoing approval process for the Digid Cantisense™ SARS-CoV-2 test in Germany. The aim of the clinical trials is to demonstrate the reliability of the new technology in comparison with conventional PCR tests. The new test is particularly suitable for access control at airports or at large-scale event
Read More
South Korean IVD Company, SUGENTECH's, COVID-19 IgM-IgG Rapid Test Listed on FDA
SUGENTECH's COVID-19 IgM&IgG 5-10 minutes rapid test kit is listed on the U.S. FDA's database and can be used in the U.S., as stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, and is planning to go further to seek EUA from U.S. FDA.
Read More
