# FDA Grants 510(k) Clearance for Revi Extend, Updated Implantable Tibial Neuromodulation Device for Women with Urinary Incontinence

> fda · REPORTED · 2026-08-05

The FDA granted 510(k) clearance on August 5, 2026 to Revi Extend by BlueWind Medical, an updated version of the implantable tibial neuromodulation Revi System for treatment of urgency urinary incontinence in women, featuring an extended device lifespan. This is a notable regulatory milestone for implantable neuromodulation in women's urological health.

About BlueWind Medical: BlueWind Medical develops the Revi System, a miniaturized implantable tibial nerve stimulation device designed to treat urgency urinary incontinence in women without the need for an external worn device.

- Company: BlueWind Medical
- Sector: medical devices
- Primary source: https://www.contemporaryobgyn.net/view/a-recap-of-top-fda-regulatory-news-from-august-2026

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