BlueWind Medical Ltd. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its enhanced Revi System wearable, which is designed to deliver therapy more effectively and seamlessly support long-term symptom relief for patients.

Since 2010, BlueWind has pioneered and advanced implantable Tibial NeuroModulation (iTNM) for urgency urinary incontinence (UUI), evolving it from an early concept into a well-established therapeutic option supported by a strong body of clinical evidence, according to the company.

The updated Revi wearable features a streamlined, easy-to-use design with a smarter, user-friendly interface, while retaining the same simple, three-button control. Together, these enhancements are intended to make it easier for patients, giving them greater confidence, control, and convenience in managing their UUI.

The Revi System offers:

• Personalized therapy that adapts to each person’s unique and changing UUI symptoms with adjustable, wearable control
• Strong symptom relief, with 79% of patients achieving a ≥50% reduction in UUI*
• Exceptional patient satisfaction, with 97% of patients reporting they are satisfied*
• Excellent safety profile, with no device- or procedure-related serious adverse events, no device migrations, and no device revision procedures*
• A single, minimally invasive procedure performed under local anesthesia, requiring no trial phase

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” BlueWind Medical CEO Kerry Nelson stated. “BlueWind has been at the forefront of the field, pioneering implantable tibial neuromodulation for UUI. Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve. The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use. All of this helps patients achieve durable symptom relief and overall satisfaction.”

BlueWind Medical is striving to transform neuromodulation therapy by developing patient-centric medical technology for disease treatment. BlueWind’s Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA clearance for UUI patients. Revi reportedly is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating “step-therapy.”

* Based on two-year follow-up data from treatment with BlueWind Revi in the OverActive Bladder Stimulation System Study (OASIS).