Visby Medical announced today that it received FDA emergency use authorization (EUA) for its Respiratory Health point-of-care test. San Jose, California–based Visby designed its polymerase chain reaction (PCR) test for the fast detection of respiratory infections. Influenza (flu) A and B, as well as SARS-CoV-2 (COVID-19) can cause these upper respiratory infections. The PCR test […]
Visby Medical
Medline to distribute Visby handheld STI test to healthcare orgs
Medline announced it is supplying Visby Medical Sexual Health Click handheld PCR test to healthcare organizations. The point-of-care device for sexually transmitted infections (STIs) is an all-in-one unit that is FDA cleared to provide a diagnosis in under 30 minutes. The company will provide the tests to urgent care centers, student health centers, women’s health […]
Visby Medical raises $135M in expanded Series E
Visby Medical announced today that it added $35 million to an expanded, oversubscribed Series E financing round. San Jose, California–based Visby plans to use the additional investment, which brings its Series E to $135 million in total, to scale production capacity, expand its product menu to include respiratory health tests and anti-microbial resistance panels and […]
Visby Medical triggers $25.5M contract option with BARDA to develop at-home COVID-19/flu test
Visby Medical announced today that it picked up $25.5 million in government funding to develop an at-home flu/COVID-19 diagnostic. San Jose, California-based Visby executed an option in a contract from the Biomedical Advanced Research and Development Authority (BARDA) on the additional $25.5 million for the development and validation of the at-home combination test. The incremental […]
Visby Medical wins FDA authorization for point-of-care COVID-19 PCR test
Visby Medical announced today that it received FDA emergency use authorization (EUA) for its rapid COVID-19 test at point-of-care. San Jose, Calif.-based Visby’s rapid PCR COVID-19 test received EUA previously but can now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, according to a news release. Visby’s testing […]
NIH announces more than $98M in contracts for new COVID-19 testing tech
The National Institutes of Health today announced six new contracts worth $98.35 million for COVID-19 testing approaches to improve sample collection, processing and results. NIH awarded the contracts in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. They cover innovations including integration with […]
