Co-Diagnostics withdrew its 510(k) application for its COVID-19 test to submit an enhanced version addressing shelf-life stability concerns. The new submission will incorporate platform improvements, ...
As we get into another winter holiday season, COVID is still part of our lives. And although it's hard to predict exactly what this year's cold, flu and coronavirus season will look like, experts want ...
SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical â„¢ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...