Navigating the Post-Public Health Emergency Landscape: How the Visby Medical Respiratory Health Test EUA Remains Unaffected
As we move into the post-public health emergency landscape with the expiration of the national emergency concerning the coronavirus disease 2019 (COVID-19) pandemic on May 11, 2023, it is essential to understand how the healthcare industry has adapted and evolved to address the unique challenges posed by the COVID-19 pandemic.
Visby Medical™ Receives FDA Clearance and CLIA Waiver for second Generation Sexual Health Test for Women
Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its 2nd generation point of care (POC) test.
Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings
Visby Medical announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test.
