Feb. 17, 2021–Visby Medical announced FDA authorization of the company’s rapid PCR COVID-19 test for use at the point of care by organizations with a CLIA certificate of waiver.
“This latest authorization will have a dramatic impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” Gary Schoolnik, MD, chief medical officer at Visby Medical, said in a press release. “Visby’s test can now be used directly at the point of care with our most vulnerable populations, including nursing homes; for frontline health workers; to maintain patient care at places like cancer and dialysis treatment centers; and to the many schools and institutions that have undertaken the process to become CLIA-waived environments.”
The palm-size device provides results in less than 30 minutes.