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Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said.
Among the many requirements to bring your product to market is to have accurate labeling — as well as procedures in place to ensure that and any new intended uses are included.
Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.