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FDAnews Device Daily Bulletin

Bioness Receives CE Mark for Neuromodulation System

Feb. 20, 2019

Valencia, California devicemaker Bioness earned the CE Mark for its StimRouter neuromodulation device.

The system is now cleared in Europe for treating overactive bladder, a condition that impacts the quality of life of nearly half a billion people worldwide.

The product serves as a permanent solution for overactive bladder. It involves implantation of a small wire and a wearable patch over the implant that lets patients control their symptoms through gentle stimulating pulses.

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