In the last year, the FDA has approved two STD tests for at-home use that allow women to get fast diagnoses for syphilis, ...

The FDA has cleared the Visby Medical Women's Sexual Health Test for use at home to test for chlamydia, gonorrhea, and ...

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 FDA has approved the first at-home, nonprescription test for chlamydia, gonorrhea, and trichomoniasis in women. The Visby Medical Women's Sexual Health Test delivers results in 30 minutes via an ...

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 ...

Intended for use by women with or without symptoms, Visby Medical’s diagnostic test can be purchased over-the-counter (OTC) without a prescription and performed at home. Supplied with a vaginal ...

Women with or without symptoms can use the Visby Medical Women’s Sexual Health Test to test for these three sexually transmitted infections (STIs). Results are delivered in about 30 minutes. The ...

Credit: Visby Medical. The approval was based on a clinical study that included 2203 females aged 14 years and older. The Food and Drug Administration (FDA) has cleared the Visby Medical Women’s ...