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FDA blows good news Bluewind's way with de novo approval for urgency incontinence device

The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves. ....

Bluewind Medical Ltd , Bluewind Medical , Medtronic Plc , Axonics Modulation Technologies Inc , Overactive Bladder , Urinary Incontinence , Bluewind Medical Ltd , Uro Medical Ltd , Percutaneous Tibial Nerve Stimulation , Urge Urinary Incontenance ,