On Tuesday, Neuralink, Elon Musk’s brain-chip startup, announced that its experimental implant, aimed at restoring vision, has been granted the “breakthrough device” designation by the U.S. Food and Drug Administration (FDA). The FDA grants the breakthrough tag to specific medical devices that provide treatment or diagnosis for life-threatening conditions, with the aim of expediting the development and review process for devices currently under development.
According to Musk, the experimental device, named Blindsight, “will enable even those who have lost both eyes and their optic nerve to see.” Neuralink did not immediately respond to a request for details on when the Blindsight device is expected to move into human trials, and the FDA also did not immediately respond to a request for comment.
Neuralink, established in 2016 by Musk and a group of engineers, is developing a brain chip interface that can be implanted within the skull. The company claims that this technology could eventually help disabled patients to move and communicate again, and also restore vision. Neuralink’s device contains a chip that processes and transmits neural signals, which could be transmitted to devices such as a computer or a phone.
Additionally, the startup is conducting a separate trial for an implant designed to provide paralyzed patients with the ability to use digital devices through thought alone. This prospect could potentially assist people with spinal cord injuries. The trial is expected to enroll three patients to evaluate the device in a study that is anticipated to take several years to complete, according to details on the U.S. government’s clinical trials database.
Earlier this year, Neuralink successfully implanted the device in the second patient, who has been using it to play video games and learn how to design 3D objects.
