Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s health, today announced that the Viveve System has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA). In the United States the Viveve System is now indicated for use in general surgical procedures for electrocoagulation and hemostasis.
“FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to bring this safe and effective technology to patients in the United States who can benefit from it,” said Patricia Scheller, chief executive officer of Viveve. “We are grateful to all of the clinicians and researchers who have supported the development of the Viveve System over the past several years, and to all of the members of the Viveve team who played a vital role in helping us achieve this goal.”
“This clearance represents the first step in our U.S. regulatory strategy,” Scheller added. “In September 2016, we announced that the company filed an Investigational Device Exemption (IDE) to the FDA, for authorization to begin the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE II) study.”
Viveve Medical, Inc. is a women’s health company passionately committed to advancing new solutions to improve women’s overall well-being and quality of life. The Viveve System has received regulatory approval in 45 countries throughout the world and is available through physician import license in Japan.