Visby Medical™ Submits Men’s Sexual Health Test to FDA Read more

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Visby Medical - Press Release

Visby Medical Submits Men‘s Sexual Health Test to FDA for Clearance and CLIA Waiver

Visby Medical has submitted its Men’s Sexual Health Test to the FDA for clearance and CLIA waiver, which would provide PCR results for Chlamydia and Gonorrhea detection from male urine samples in under 30 minutes if cleared. The single-use, instrument-free point-of-care test requires no capital investment or maintenance and can be easily integrated into diverse clinical settings including urgent care centers and physician offices. This submission expands Visby Medical’s sexual health diagnostic portfolio and helps address the critical need for streamlined STI testing.

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Visby Medical - Press Release

Visby Medical™ Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

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. With plans for strategic partnerships and expansion into additional diagnostic markets, the company positions itself to capitalize on the growing demand for convenient, private healthcare solutions.

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Visby Medical - Press Release

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible.

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Visby Medical - Press Release

Visby Medical Secures Additional $3.9M from CARB-X to Fight Antibiotic Resistance with PCR-Based Mutation Detection at the POC

Point-of-Care test significantly shortens time from ED arrival to test results, treatment and discharge – significant improvements are seen in the use of antibiotics for the treatment of chlamydia and gonococcal infections in women. Nationwide increases in sexually transmitted diseases and antibiotic resistance create the need for a paradigm shift from traditional lab-based molecular testing.

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Visby Medical - Press Release

Visby Medical™ Sexual Health Test Results in More Appropriate Antibiotic Treatment and Shorter Emergency Department Visits Than Standard of Care

Point-of-Care test significantly shortens time from ED arrival to test results, treatment and discharge – significant improvements are seen in the use of antibiotics for the treatment of chlamydia and gonococcal infections in women. Nationwide increases in sexually transmitted diseases and antibiotic resistance create the need for a paradigm shift from traditional lab-based molecular testing.

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