Neuralink, Elon Musk’s brain-chip startup, said on Tuesday its experimental implant, intended to restore vision, had received the breakthrough device designation from the US Food and Drug Administration. FDA has a breakthrough tag available for certain medical devices providing treatment or diagnosis of life-threatening or irreversibly debilitating conditions. It is aimed at speeding up development and review of devices currently under development. The experimental device, called Blindsight, “will enable even those who have lost both eyes and their optic nerve to see,” Musk said, in a post on X.
Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment. Founded in 2016 by Musk and a team of engineers, Neuralink is developing a brain chip interface that can be implanted within the skull, which it says could eventually help disabled patients to move and communicate again and also restore their vision. Neuralink’s device has a chip that processes and transmits neural signals, which may then be sent to devices such as a computer or even a phone.
The startup is separately testing an implant designed to give paralyzed patients the ability to use digital devices by thinking alone—a prospect that could help people with spinal cord injuries. In this trial, the company is expected to enroll three patients in order to study its device, expected to take several years to complete, according to details on the U.S. government’s clinical trials database. Earlier this year, Neuralink implanted the device in the second patient—who has since used it to play video games, among other uses—and is learning to design 3D objects.