The US Food and Drug Administration (FDA) has authorised the first at-home PCR STI test for chlamydia, gonorrhoea, and ...

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 ...

The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for ...

The Visby Medical Women’s Sexual Health Test’s de novo authorisation was supported by a study of 2,000 users in which it achieved high accuracy ratings for each of the STIs it tests for. Image credit: ...

SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...

The FDA granted marketing authorization to a Visby Medical at-home PCR test for three common sexually transmitted infections. The Visby test yields results in about 30 minutes. Balancing ...

The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway for more to come.

A new FDA authorized over-the-counter test from Visby Medical essentially puts the lab in the user’s hand. The FDA on Friday granted marketing authorization to the Visby Medical Women’s Sexual ...

The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic ...

The US Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women.