Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Shots: The US FDA has granted clearance to Flu and COVID-19 Test, an at-home PCR test capable of detecting multiple respiratory viruses, expanding its portfolio of over-the-counter molecular diagnostics The test delivers PCR-quality results in 30min. & detects COVID-19 and influenza A/B at home, enabling earlier diagnosis & timely treatment decisions, incl. access to antiviral…

ByRidhi RastogiJuly 3, 2026

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…

ByRidhi RastogiMarch 31, 2025

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

Shots: The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19) Under the…

ByRidhi RastogiFebruary 28, 2025

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

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