Neuralink gets FDA ‘breakthrough device’ designation for ‘blindness’ implant

Elon Musk’s brain-chip startup Neuralink said on Tuesday that its experimental implant designed to restore vision received “breakthrough device” designation from the U.S. Food and Drug Administration.

The FDA’s breakthrough designation is granted to certain medical devices intended to treat or diagnose life-threatening conditions. The designation is intended to expedite the development and review of devices currently under development.

In a post on X’s website, Musk said the experimental device, called Blindsight, could “allow sight to return even to people who have lost both eyes and their optic nerves.”

Neuralink did not immediately respond to a request for details about when the Blindsight device is expected to enter human trials. The FDA also did not immediately respond to a request for comment.

Neuralink, founded by Musk and a group of engineers in 2016, is developing a brain-chip interface that can be implanted inside the skull, which it says could eventually help disabled patients move and communicate again and restore vision.

Neuralink’s device has a chip that processes and transmits neural signals, which can be transmitted to devices such as computers or mobile phones.

The startup is separately testing an implant designed to enable paralyzed people to use digital devices simply by thinking about them, a prospect that could help people with spinal cord injuries.

The trial is expected to enroll three patients to evaluate its device, and the study is expected to take several years to complete, according to details in a U.S. government clinical trials database.

Earlier this year, Neuralink successfully implanted the device into a second patient, who has been using it to play video games and learn how to design 3D objects.