The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus.
“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. 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,” CEO Patricia Scheller said in a press release. “This clearance represents the first step in our U.S. regulatory strategy. In September 2016, we announced that the company filed an Investigational Device Exemption to the FDA, for authorization to begin the Viveve treatment of the vaginal introitus to evaluate efficacy study.”
In early September, Viveve said it won regulatory clearance from Australia’s Therapeutic Goods Administration, and a month earlier claimed a win from the Ministry of Food and Drug Safety in South Korea for the Viveve system.
In July, Viveve said it inked 6 new distribution deals to expand the availability of its Viveve system to 14 Latin American countries.
The women’s health company said it inked deals with Sirex S.A., Torregal, Alphaeon Columbia S.A.S., Vitre-Tech, Coolmed S.A., Adenor S.A. and MARC Group International to bring the system to Argentina, Peru, Paraguay, Chile, Ecuador, Mexico, Panama, Costa Rica, Guatemala and the Dominican Republic.