Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.
Source: BioSpace, July 7, 2020