FDA Grants Neuralink’s ‘Blindsight’ Breakthrough Status

Elon Musk’s brain-chip business Neuralink announced Tuesday that its vision-restoring implant has been certified as a “breakthrough device” by the FDA

FDA-designated breakthrough medical gadgets treat or diagnose life-threatening illnesses. It accelerates gadget development and review.

Musk stated Blindsight “will enable even those who have lost both eyes and their optic nerve to see,” opening a new tab on X.

When Neuralink anticipates the Blindsight device to enter human trials, it was not immediately responded to. A request for comment from the FDA was also delayed.

Neuralink, founded in 2016 by Musk and a team of engineers, is developing a brain chip interface that can be implanted in the skull to let injured individuals move, communicate, and see again.

A chip in Neuralink’s device processes and sends neural impulses to computers and phones.

Separately, the business is researching an implant enabling spinal cord injury sufferers to utilize digital gadgets by thinking.

The U.S. government’s clinical trials database reports that this experiment will enroll three patients to evaluate its gadget over several years.

The second patient learned to construct 3D things and play video games after Neuralink implanted the device earlier this year.