Elon Musk’s brain-chip startup, Neuralink, has announced that its Blindsight experimental implant, aimed at restoring vision, has been granted the US Food and Drug Administration’s (FDA) “breakthrough device” designation.
This status is reserved for medical devices that offer treatment or diagnosis for life-threatening conditions, accelerating their development and review process.
Blindsight is designed to enable even individuals who have lost both eyes and their optic nerve to regain their vision, according to Musk, who shared the news in a post on X. Neuralink has not yet provided details on when human trials for the device might begin, and the FDA has yet to comment on the timeline.
Founded in 2016, Neuralink is developing brain-chip interfaces that can be implanted within the skull to help disabled patients regain the ability to move, communicate, and, in this case, restore vision. The chip processes and transmits neural signals that can be linked to devices such as computers or phones.
In addition to Blindsight, Neuralink is testing another implant designed to enable paralysed individuals to control digital devices purely through thought. This trial, listed in the US clinical trials database, will involve three patients and is expected to take several years to complete.
Earlier this year, Neuralink successfully implanted its device in a second patient, who has since been using it to play video games and learn how to design 3D objects.