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

SAN JOSE, Calif., March 28, 2025 /PRNewswire/ — Today, Visby Medicalâ„¢, 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….