Neuralink, Elon Musk’s brain-chip startup, announced that its experimental vision-restoring implant, "Blindsight," has received the U.S. Food and Drug Administration’s (FDA) "breakthrough device" designation.
This special status is aimed at expediting the development and review of medical devices that treat life-threatening conditions.
According to Musk, Blindsight could enable even those who have lost both eyes and their optic nerve to regain vision.
While Neuralink has not yet provided details on when the device will enter human trials, the breakthrough designation suggests a faster regulatory path. The FDA has not yet commented on the announcement.
Founded in 2016, Neuralink aims to develop brain-chip interfaces that can be implanted in the skull to help disabled individuals regain abilities such as movement and communication. The company's chips process neural signals and can connect to external devices like computers or smartphones.
Neuralink is also testing a brain implant to help paralyzed patients control digital devices using their thoughts. This trial is expected to take several years, with three patients enrolled. Earlier this year, the company successfully implanted its chip in the second patient, who is now using it to play video games and design 3D objects.