The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis. The single-use, point-of-care test delivers results in under 30 minutes ...
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain ...
SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical(TM), a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...
The FDA granted marketing authorization to a Visby Medical at-home PCR test for three common sexually transmitted infections. The Visby test yields results in about 30 minutes. Balancing healthcare ...
The firm hopes to exploit its first-mover advantage in the OTC space following de novo clearance for an at-home PCR test to detect sexually transmitted infections.
The US Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby Medical’s polymerase chain reaction (PCR) test to detect ...
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, ...
If cleared, Visby Medical's test will provide fast PCR results for Chlamydia and Gonorrhea using male urine samples in diverse clinical settings, meeting clinical demand and established medical ...
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