Blindsight is Neuralink's visual cortex prosthesis designed to restore vision in individuals with bilateral blindness, including those blind from birth, as long as the visual cortex is intact. The device bypasses the eyes entirely — an external camera captures images and sends data wirelessly to a brain implant in the visual cortex, which stimulates neurons to create visual percepts. Initial resolution is expected to be low (comparable to early Atari graphics) but could improve with technology advancement. The device received FDA Breakthrough Device Designation in September 2024. Preclinical testing in non-human primates has been ongoing for over three years.
FDA Breakthrough Device Designation provides more interactive communication with FDA during development and a priority review pathway. The device is still under investigation and not yet approved for commercial sale.
FDA Device Regulatory Guidance ↗