03/14/2023
•2023Press Release
Visby Medical™ Receives FDA Clearance and CLIA Waiver for second Generation Sexual Health Test for Women
Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its 2nd generation point of care (POC) test.
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About Visby Medical™
Visby Medical is transforming the order of diagnosis and treatment for infectious diseases so clinicians can test, talk with, and treat the patient in a single visit. The Company developed a proprietary technology platform that is the world’s first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections. The Visby Medical Sexual Health Test for women is the first step in a robust pipeline that is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home. For more information, visit www.visbymedical.com. Follow Visby Medical on LinkedIn.Read more articles & insights
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