FDA grants 510(k) clearance to enhanced Revi System for urgency urinary incontinence

On December 16, 2025, the FDA granted 510(k) clearance to an enhanced iteration of the Revi System, an implantable tibial neuromodulation (iTNM) device for patients with urgency urinary incontinence (UUI), BlueWind Medical announced in a news release.¹

The Revi System was initially approved for marketing in the US in August 2023.² The System is powered by an external, battery-operated wearable that adapts simulation to each patient’s unique UUI symptoms. According to BlueWind, the enhanced device now includes “a streamlined, easy-to-use design with a smarter, user-friendly interface, while retaining the same simple, three-button control.”

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” said Kerry Nelson, CEO of BlueWind Medical, in the news release.¹ “BlueWind has been at the forefront of the field, pioneering implantable tibial neuromodulation for UUI.”

The safety and efficacy of the Revi System were demonstrated in the pivotal OASIS trial (NCT03596671), in which treatment with the device showed durable efficacy and a favorable safety profile.³ In total, the prospective, single-arm, open-label study enrolled 151 women with UUI, including urinary urgency. Participants were enrolled in the study through clinical trials sites across the US, the Netherlands, Belgium, and the United Kingdom.

Overall, the trial demonstrated strong symptom relief, with 79% of patients achieving at least a 50% reduction in UUI episodes per a 3-day voiding diary. At 6-, 12-, and 24-months, the responder rates were 78%, 82%, and 79%, respectively.

According to the authors, “Participants who completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population.”

The study also showed positive patient perceptions of treatment, with 97% of participants reporting feeling satisfied with the therapy and 80% reporting feeling “much better” or “very much better” after treatment.

No serious device- or procedure-related adverse events were reported through 24 months. Further, no device migrations or device revision procedures were required.

“Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve,” Nelson concluded in the news release.¹ “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.”

REFERENCES

1. BlueWind Medical receives FDA 510(k) clearance for enhanced Revi® wearable supporting long-term treatment of urgency urinary incontinence. News release. BlueWind Medical. December 16, 2025. Accessed December 16, 2025. https://www.businesswire.com/news/home/20251216057440/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Enhanced-Revi-Wearable-Supporting-Long-Term-Treatment-of-Urgency-Urinary-Incontinence

2. BlueWind Medical’s Revi™ System secures U.S. FDA de novo classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed December 16, 2025. https://bluewindmedical.com/resource/bluewind-medicals-revi-system-secures-u-s-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence/

3. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. J Urol. 2025;213(3):323-332. doi:10.1097/JU.0000000000004328