UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Read more.

Source: PRNewswire, April 20, 2023

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.

Source: PRNewswire, November 29, 2022