ReVision Implant Wins FDA Breakthrough Status for Brain-Based Vision Restoration Device

Summary

Belgian startup ReVision Implant received FDA Breakthrough Device Designation for Occular, a visual prosthesis that bypasses the eye and optic nerve entirely by stimulating the brain's visual cortex directly, rather than the retina as most competing devices do. A camera mounted on a wireless headset captures images and sends the data to an implant of ultra-flexible microelectrodes; the resulting stimulation patterns register to the wearer as discrete points of light, which the brain can learn to assemble into simple visual representations. Because it acts downstream of both the eye and optic nerve, the company says Occular could potentially help patients with a broader range of blindness causes than retinal implants can address. ReVision, founded in 2020 by Frederik Ceyssens and Peter Janssen at KU Leuven, plans a short-term trial during a scheduled brain surgery in October 2026, ahead of first-in-human trials in blind volunteers targeted for 2027.