STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. STeP covers devices that could improve the safety of treatments or diagnostics. They treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.
The agency cleared a gastric calibration tube in March, marking the first authorization of a device under the program.
“We are delighted to receive this designation and excited to advance the development of our UroActive system – the first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems CEO and co-founder. “We thank the FDA for acknowledging the importance of safety above all for patients.”
About UroActive
UroActive, a smart implant powered by a MyoElectroMechanical system (MEMS), treats stress urinary incontinence (SUI).
Placed around the urethral duct, the system offers automatic control based on the patient’s activity. It eliminates the need for manual adjustments, aiming to offer better ease of use and quality of life compared to current options.
UroMems says it intends to restore quality of life, dignity and self-esteem in millions of men and women with poorly treated chronic conditions.
“The STeP approval is proof that the FDA recognizes the potential for UroActive to improve upon safety for patients with severe SUI, while also designed for an improved surgical experience for the OR team, surgeons and most importantly, their patients,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.
