San Jose, Calif. – Feb. 26, 2025 – Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid polymerase chain reaction (PCR) test that detects and differentiates between upper respiratory infections caused by influenza (Flu) A & B, and SARS-CoV-2 (COVID-19). This multiplexed molecular device is the first handheld test to receive this designation after being granted Emergency Use Authorization (EUA) in December 2022.
The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible.
“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,” said Dr. Gary Schoolnik, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University. He added, “Fast diagnosis of patients with respiratory symptoms — enabling selection of the most appropriate treatments — is increasingly important to the medical community.”
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00019. Additional BARDA-funded studies are ongoing to support the advanced development of features that would support an at-home respiratory test to further aid in patient care and management decisions.
About Visby Medical™
Founded in 2012, Visby Medical is transforming the order of diagnosis and treatment for infectious diseases so clinicians can test, talk with, and treat the patient in a single visit. The Company developed a proprietary technology platform that is the world’s first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections. Their commercialized point-of-care tests for sexually transmitted infections (STIs) and respiratory infections (COVID-19 and the flu) deliver true PCR results in under 30 minutes.
For more information, visit www.visby.com. Follow Visby Medical on LinkedIn.
