# FDA Grants 510(k) Clearance to BlueWind Medical's Revi Extend Implant for Urgency Urinary Incontinence

> fda · REPORTED · 2026-08-05

The FDA granted 510(k) clearance to BlueWind Medical's Revi Extend, a next-generation implantable tibial neuromodulation device for urgency urinary incontinence with an extended device lifespan of 15 years. Supported by 3-year OASIS pivotal trial data showing 79% of patients achieved at least a 50% reduction in UUI episodes and 95% reported satisfaction, BlueWind plans a limited US launch in Q4 2026.

About BlueWind Medical: BlueWind Medical develops the Revi System, an implantable tibial neuromodulation device implanted near the ankle that delivers targeted electrical stimulation to the posterior tibial nerve to treat urgency urinary incontinence in women.

- Company: BlueWind Medical
- Sector: medical devices
- Primary source: https://www.businesswire.com/news/home/20260805290667/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Revi-Extend-Implant

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.