FDA Clearance

February 2019

On February 7, 2019, UroCure announced FDA 510(k) Clearance of its ArcTV® Transvaginal Sling System for the treatment of female stress urinary incontinence (SUI). Developed in collaboration with leading physicians, the system maintains familiar features of transvaginal retropubic sling systems while incorporating enhancements to optimize product safety and efficacy.    

The ArcTV sling is UroCure’s first product and is reflective of a leading-edge approach in the medical device industry. As part of the ArcTV’s launch, UroCure is committing to tracking outcomes for the first 500 patients treated with its sling. In partnership with The American Urogynecological Society (AUGS), UroCure is building a network of physicians within the AUGS AQUIRE Registry to collect long-term data on post-operative outcomes.

In addition to the registry, UroCure has established a Quality and Safety Oversight Committtee (QSOC) comprised of leading academic physicians who will monitor outcomes and provide guidance to UroCure’s activities moving forward.  

“We are excited to be the first sling company to launch a product into a physician medical society registry (AUGS). We believe this data-driven approach is the wave of the future and will be beneficial to both patients and physicians, resulting in improved overall care,” reported John Nealon, UroCure President and CEO.  

UroCure was founded with the goal of improving the quality of life for women suffering from stress urinary incontinence. Everything we do starts with listening to women and their doctors about what works best for them. For more information about this or other aspects of our company, please reach out to John at or contact us at