Visby Medical’s handheld PCR test that differentiates between Flu A, Flu B, and COVID-19 received FDA clearance and a CLIA waiver.


RT’s Three Key Takeaways

  1. The FDA has granted 510(k) clearance and a CLIA waiver for the Visby Medical Respiratory Health Test, a handheld PCR test that differentiates between Influenza A, B, and COVID-19.
  2. This rapid test delivers accurate results in under 30 minutes at the point of care, making it a valuable tool for clinicians in remote or resource-limited settings.
  3. Supported by federal funding from BARDA, ongoing studies aim to develop an at-home version of the test to enhance patient care and management.


Visby Medical has received FDA 510(k) clearance and was granted a CLIA waiver for the Visby Medical Respiratory Health Test, from a point-of-care respiratory health test.

The 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.”