Visby Medical Reports the US FDA’s De Novo Authorization of its Women's Sexual Health Test for Over-the-Counter Use
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- 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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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
