June 2025—Visby Medical announced it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its point-of-care Medical Respiratory Health test. The PCR test detects and differentiates between upper respiratory infections caused by influenza A and B and SARS-CoV-2 and provides results in less than 30 minutes.
Visby Medical, 833-468-4729