Neuralink’s ‘Blindsight’ receives innovative device designation from FDA

Neuralink, Elon Musk’s brain chip startup, declared that its experimental implant intended to restore vision has received “breakthrough device” designation from the U.S. Food and Drug Administration (FDA).

The FDA innovator label is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is intended to expedite the development and review of devices currently under development.

The experimental device, known as Blindsight, “will allow even those who have lost both eyes and their optic nerve to see,” Musk said in a posting on X.

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