Neuralink, Elon Musk's brain-chip startup, announced on Tuesday that its experimental implant designed to restore vision, known as "Blindsight," has received the U.S. Food and Drug Administration's (FDA) "breakthrough device" designation. This label is granted to medical devices that offer new treatments or diagnostics for serious conditions, aimed at expediting their development and review. Musk stated in a post on X that the Blindsight implant could potentially enable individuals who have lost both eyes and their optic nerves to regain vision.
While Neuralink has not yet provided details on when the Blindsight device may enter human trials, the FDA also did not offer immediate comment. Neuralink, founded in 2016 by Musk and a team of engineers, is focused on creating brain-chip interfaces that can be implanted in the skull. The goal is to help disabled patients regain mobility, communication, and even vision. The implant's chip processes neural signals, which can be transmitted to devices like computers or smartphones.
In addition to Blindsight, Neuralink is also testing another implant aimed at helping paralyzed patients control digital devices using just their thoughts, potentially benefiting those with spinal cord injuries. This ongoing trial plans to enroll three participants, with the study expected to take several years. Earlier this year, Neuralink successfully implanted the device in its second patient, who has since been using it to play video games and learn 3D design.