Yōni.Fit received 510(k) clearance from the US Food and Drug Administration (FDA) in August 2024 following completion of a national clinical trial by Urogynecologists at Stanford, NYU, and Jefferson Health.
"Nearly 3 in 4 women worldwide suffer from SUI, and for years have been suffering in silence because the treatments can be perceived as intimidating or invasive.”
- Dr. Benjamin M. Brucker, Assistant Professor of Urology + Gynecology & Obstetrics, NYU
