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Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

on June 11, 2025

SAN JOSE, Calif. — Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the Visby Medical Women’s Sexual Health Test for Over the Counter (OTC) use. This groundbreaking test enables reliable, rapid, and private at-home...

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Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs
Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs
Consumers Now Have More Choices to Purchase the Visby Device Featuring 30-Minute, Lab-Quality ResultsSAN JOSE, Calif. – Jan. 8, 2026 – Today, Visby Medical™ announced two new relationships that will expand national access to the Visby Women’s Sexual Health Test, the first, at-home, FDA-authorized PCR test for sexually transmitted infections (STIs) available to consumers, enabling... Read more...
Visby Medical Tackles STI Epidemic with First At-Home FDA-Authorized PCR Test in Partnership with Google Cloud
Visby Medical Tackles STI Epidemic with First At-Home FDA-Authorized PCR Test in Partnership with Google Cloud
The Company’s New Rapid Women’s Sexual Health Test is Accessible Today via Direct-to-Consumer Partnerships with Everlywell, DoorDash, and GoPuff SAN JOSE, Calif.-- Visby Medical™ today announced the national launch of the first-of-its-kind FDA-authorized at-home PCR test for sexually transmitted infections (STIs) in women, redefining how sexual health is diagnosed and treated. The palm-sized test, now... Read more...

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