Now accepting Telehealth appointments. Schedule a virtual visit.
Skip to main content

Viveve Supports the FDA's Stance on the Importance of Patient Safety

Viveve Supports the FDA's Stance on the Importance of Patient Safety

In response to the recent safety warnings released by the FDA, Viveve released the below statement outlining the company’s support of patient safety and evidence‐based medicine:

To: Our Providers & Patients:
Given the FDA’s recent actions against certain companies marketing devices for vaginal rejuvenation procedures, we wanted to provide a response regarding the demonstrated safety and efficacy of our CMRF (cryogen‐cooled monopolar RF) technology. Importantly, Viveve was NOT one of the seven companies included in the FDA vaginal rejuvenation safety statement and has NOT received a warning letter.
The company views the FDA statement as a positive for the industry and for Viveve since it highlights the importance of patient safety and evidence‐based medicine. Our company, and our CMRF technology platform, have been built to provide safe treatments with proven clinical benefits.
Viveve currently has regulatory approvals or clearances in over 50 countries for the treatment of vaginal laxity and/or sexual function, and in Argentina for the treatment of mild urinary incontinence. We continue to pursue additional regulatory approvals documenting the safety and efficacy of our device for the treatment of gynecological and urological conditions, as demonstrated by:

It is important to note that the FDA and other global regulatory agencies grant approvals to proceed with human clinical trials based on extensive safety testing. Viveve has completed multiple pre‐clinical studies to thoroughly characterize the effect of our CMRF treatment, which clearly demonstrated that there was no injury to vaginal and surrounding tissues.
Viveve is committed to providing safe devices for use in clinical practice backed by high‐quality, clinical data as evidenced by:

We thank you for your continuing support in our efforts to provide safe and effective treatments that address prevalent women’s intimate health conditions.
Please feel free to contact us at if you have any further questions or concerns.
Scott Durbin Jim Atkinson
Chief Executive Officer President and Chief Business Officer

You Might Also Enjoy...

How to Help Your Child Manage Diabetes At School

Diabetes is a serious medical condition that can be difficult to manage at any age. If a child has diabetes, it can be especially challenging to manage, particularly in a school setting. Read on to learn how you can help your child.

I Have an STD — Now What?

If you have a sexually transmitted disease (STD), you’re not alone. In fact, they’re very common. Read on to learn about the basics of STDs and how they’re treated.

What’s Involved in My Child’s Sports Physical

The popularity of youth sports is a given. Just ask any soccer mom or check out your local athletic fields on a Saturday. What’s perhaps not so obvious is the role your child’s sports physical plays. Read on.

How Much Sleep Is Too Much for My Teen?

Getting sufficient sleep is important whether you’re age 8, 18, or 80. But, can there be too much of a good thing when it comes to your teenager? Read on to find out.