February 11, 2021 – Visby Medical announced that the US Food and Drug Administration (FDA) authorized the company’s rapid PCR COVID-19 test for use at the point of care (POC).
Building on the FDA’s emergency use authorization granted earlier this year, Visby Medical’s rapid PCR COVID-19 test may now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver.
By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical says its test is able to provide fast, accurate, and actionable results at the point of care.
Visby Medical will continue to work to expand authorized use cases to help provide a sense of security to critical areas of our healthcare system, military, consumer businesses and schools, providing a means for these institutions to reopen and allow people to return to work safely, the company says.