Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots:

• The US FDA has granted De Novo authorization to Visby Medical Women’s Sexual Health Test for OTC use
• Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options
• Visby Medical Women’s Sexual Health Test is a PCR diagnostic device that delivers results directly to users within 30min., allowing rapid diagnosis of chlamydia, gonorrhea, & trichomoniasis

Ref: Prnewswire | Image:  Visby Medical

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