FDA Clears Diagnostic Aimed At Reducing STDs In Women

The US Food and Drug Administration has granted 510(k) clearance to Visby Medical for its product designed to diagnose three of the most common sexually transmitted infections in women.

STI test
• Source: Shutterstock

Visby Medical has received 510(k) clearance for its sexual health test, a second-generation polymerase chain reaction (PCR) diagnostic that uses a self-collected vaginal swab to detect three common sexually transmitted infections (STIs) – chlamydia, gonorrhea, and trichomoniasis.

The San Jose, CA-based medtech company also received a CLIA waiver for the test, which the FDA grants to diagnostics with little to no risk, such as cholesterol or pregnancy...

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