
Sexual Health Test — POC rapid PCR device - Visby Medical
The Visby Medical Sexual Health Test detects three of the most common and curable STIs: Chlamydia, Gonorrhea, Trichomoniasis — in under 30 minutes — so you can provide data-driven treatment in the same visit.
FAQ - Visby Medical
Visby Medical delivers innovation that makes PCR fast, accessible, affordable, and simple: Immediacy to test within ~30 minutes and helps to ensure appropriate treatment during a single patient visit, and freedom from instrument commitment and maintenance.
Home | Visby Medical
Visby Medical is a medical diagnostics company with portable PCR testing technology for both clinical and mobile laboratory settings.
Visby Medical™ Receives FDA Clearance and CLIA Waiver for …
Mar 14, 2023 · Visby Medical™ secured FDA De Novo authorization for the first OTC PCR sexual health test for women, marking a significant market entry into at-home diagnostics. The innovative, palm-sized device enables rapid, reliable testing for three common sexually transmitted infections, addressing a substantial unmet medical need.
Visby Medical™ Receives FDA Clearance and CLIA Waiver at the …
Aug 30, 2021 · Visby Medical™ secured FDA De Novo authorization for the first OTC PCR sexual health test for women, marking a significant market entry into at-home diagnostics. The innovative, palm-sized device enables rapid, reliable testing for three common sexually transmitted infections, addressing a substantial unmet medical need.
Read more articles & insights - Visby Medical
Jun 12, 2024 · A groundbreaking study from Johns Hopkins Medicine found that the Visby Medical point-of-care (POC) Sexual Health Test significantly improved management of three of the most common non-viral sexually transmitted infections (STIs) in women compared to standard laboratory testing.
The Visby Medical Sexual Health Test is a single-use (disposable), fully integrated, rapid, compact device containing a PCR-based assay for direct qualitative detection and differentiation of DNA from CT, NG, and TV.
Visby Medical™ Sexual Health Test Results in More Appropriate ...
May 30, 2024 · Visby Medical™ secured FDA De Novo authorization for the first OTC PCR sexual health test for women, marking a significant market entry into at-home diagnostics. The innovative, palm-sized device enables rapid, reliable testing for three common sexually transmitted infections, addressing a substantial unmet medical need.
Clinical Data of The Visby Medical Sexual Health Click Test …
Dec 1, 2021 · Visby Medical™ secured FDA De Novo authorization for the first OTC PCR sexual health test for women, marking a significant market entry into at-home diagnostics. The innovative, palm-sized device enables rapid, reliable testing for three common sexually transmitted infections, addressing a substantial unmet medical need.
STI Testing: New Point-of-Care Advances | Visby Medical
In August, Visby Medical received FDA clearance and a CLIA waiver for its point-of-care PCR test for the detection of chlamydia, gonorrhea, and trichomonas with a vaginal swab. Results are available within 30 minutes and can be shared within a single patient visit.