Industry News
BlueWind Medical receives FDA 510(k) clearance for the Revi Extend implant
BlueWind Medical received FDA 510(k) clearance on 5 August 2026 for Revi Extend, an updated version of its implantable posterior-tibial-nerve neuromodulation device with implant longevity extended from 10 to 15 years. Revi Extend is the second 510(k) in the Revi family; the base Revi System was authorised in August 2023 via FDA De Novo classification grant. OASIS three-year data supported the update. Revi is a peripheral-nerve stimulator, not a brain-computer interface, and is covered under InsideBCI's bioelectronic-medicine adjacency scope.