News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears BlueWind's Revi Extend Tibial Implant for Urgency Incontinence

The next-generation implant is intended to last 15 years instead of 10; BlueWind plans a limited US launch in the fourth quarter.

By News DeskAugust 5, 20262 min read
Labelled illustration of the urinary bladder with a magnified view of its wall tissue
An anatomy illustration of the urinary bladder and its muscle layers. Not related to the Revi Extend device. OpenStax College, CC BY 3.0, via Wikimedia Commons · CC BY 3.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • BlueWind Medical announced FDA 510(k) clearance of Revi Extend on August 5, 2026; the FDA database lists a Revi System clearance, K253651, dated July 28.
  • The implant sits near the ankle and is powered by an external wearable, with no implanted battery or leads.
  • Three-year OASIS data on the earlier Revi implant showed 79% of evaluable women with at least a 50% reduction in incontinence episodes.

The US Food and Drug Administration has cleared BlueWind Medical's Revi Extend, a next-generation version of the company's implantable tibial neuromodulation device for urgency urinary incontinence, with an intended implant life of 15 years instead of 10, Urology Times reported on August 5, citing the company's announcement that day.

According to the company, as reported by Urology Times, Revi Extend will be introduced through a limited US launch in the fourth quarter of 2026. The clearance builds on the original Revi System, which received its first FDA authorization in August 2023, and keeps the same therapy platform.

What the FDA record shows

The FDA's 510(k) database lists a clearance for BlueWind Medical's Revi System, submission K253651, with a decision of substantially equivalent dated July 28, 2026. The traditional 510(k) was received on November 20, 2025, and reviewed by the gastroenterology and urology panel. The device is classified as an implanted tibial electrical urinary continence device, product code QXM. Neither the company's announcement nor Urology Times gave a submission number for Revi Extend, and the database entry uses the Revi System name.

How the system works

The Revi System consists of a small implant placed next to the posterior tibial nerve near the ankle during an outpatient procedure under local anesthesia, Urology Times reported. An external wearable controller powers the implant, so no implanted battery or lead extensions are needed, and patients run stimulation sessions themselves once a day at home.

"FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians," said Kerry Nelson, BlueWind's chief executive, in the company's news release, as quoted by Urology Times.

Clinical data behind the platform

Evidence for the Revi platform comes mainly from the OASIS pivotal study, a multicenter, prospective, single-arm trial that enrolled 151 women with urgency urinary incontinence, according to Urology Times. Three-year results were published in The Journal of Urology. Of the 151 women implanted, 140 completed 12 months, 119 entered an extension study and 90 completed the 36-month evaluation.

At three years, 79% of evaluable participants had at least a 50% reduction in incontinence episodes on three-day voiding diaries, and 63% had at least a 75% reduction, the report said. No device-related or procedure-related serious adverse events were reported through three years. Those results come from the earlier Revi implant; Urology Times did not report separate clinical data for the longer-life Revi Extend.

BlueWind, based in Herzliya, Israel, according to the FDA record, did not disclose pricing for the new implant.

Sources

  1. FDA clears Revi Extend implant for urgency urinary incontinence, Urology Times, August 5, 2026
  2. 510(k) Premarket Notification K253651: Revi System, US Food and Drug Administration, July 28, 2026