US-based medical technology firm Visby Medical has received the US Food and Drug Administration (FDA) 510(k) approval and CLIA waiver for its point-of-care respiratory health test.
The Visby Medical Respiratory Health Test is a rapid polymerase chain reaction (PCR) test.
It is designed to detect and differentiate upper respiratory infections caused by influenza (Flu) A & B, and SARS-CoV-2 (Covid-19).
The multiplexed molecular device is the first handheld test to receive FDA approval after securing Emergency Use Authorisation (EUA) in December 2022.
Visby Medical platform leverages true PCR technology, which is the gold standard for testing Flu A, Flu B, and Covid-19.
According to Visby Medical, its respiratory health test fits in the palm of our hand and provides accurate test results within 30 minutes at the point of care.
It enables clinicians to accurately diagnose and treat patients even in remote care facilities and resource-limited healthcare settings, lacking access to centralised laboratory services.
Visby Medical chief medical officer Gary Schoolnik said: “This FDA decision ensures that accurate, rapid testing with the Visby Medical Respiratory Health Test will remain available to help physicians quickly diagnose and treat patients as they face upcoming respiratory seasons.
“Fast diagnosis of patients with respiratory symptoms, enabling selection of the most appropriate treatments, is increasingly important to the medical community.”
Established in 2012, Visby Medical is focused on diagnosis and treatment of infectious disease, allowing clinicians to test, consult, and treat patients in a single visit.
The company received federal funding from the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA).
Visby Medical is conducting other BARDA-funded studies to advance the development of at-home respiratory test features to enhance patient care and management decisions.
