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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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