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The implant aims to help restore vision in blind patients.
This designation allows Neuralink to work more closely with FDA experts and could speed up the development and approval process.
Blindsight, designed to allow even those without eyes or an optic nerve to see, is separate from Neuralink's Telepathy implant, which enables paralyzed patients to control devices with their minds.
Musk claims Blindsight has already shown results in monkeys, and while initial resolution may be low, it could eventually surpass normal human vision.
Despite these ambitious goals, experts remain cautious, particularly about the potential for restoring sight in individuals born blind. The technology is still in its early stages, and significant challenges remain before it can fully restore vision.