1. Medtech Insight

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By Elizabeth Orr

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

Hand holding Visby Sexual Health test kit.
(Visby Medical)

The US Food and Drug Administration has cleared the first at-home test for the detection of multiple common sexually transmitted infections (STIs) in women, creating a new regulatory pathway for similar tests in the future.

The agency announced its de novo clearance of the Visby Medical Women’s Sexual Health Test on March 28

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