BlueWind wins FDA nod for enhanced urinary incontinence wearable

BlueWind Medical announced today that the FDA granted 510(k) clearance for its enhanced Revi implantable tibial neuromodulation (iTNM) system.

Salt Lake City–based BlueWind designed the enhanced Revi wearable device to deliver therapy more effectively. It aims to seamlessly support long-term symptom relief for patients with urgency urinary incontinence (UUI).

BlueWind designed Revi for implantation near the ankle during a single outpatient procedure. Patients initiate Revi therapy at their convenience by placing a lightweight, wireless wearable around their ankle once daily. This provides stimulation to the posterior tibial nerve, offering relief from urgency urinary incontinence (UUI) symptoms.

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