Neuralink’s vision-restoring brain chip secures FDA “breakthrough” designation

Blindsight, the experimental vision-restoring implant by Elon Musk’s brain-chip startup, Neuralink, has received the U.S. Food and Drug Administration’s (FDA) “breakthrough device” designation, according to the company.
The recognition, aimed at expediting the development of life-saving medical technologies, could accelerate the path to restoring sight for those who have lost their vision entirely.
The Blindsight device, according to Musk, is designed to enable even those who have lost both eyes and their optic nerve to regain some level of vision. Announcing the development on X (formerly Twitter), Musk stated, “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.” However, Neuralink has not yet provided a timeline for when the device will begin human trials, nor has the FDA commented on when it expects to approve the next steps.
Founded in 2016, Neuralink aims to revolutionise the way humans interact with technology by developing a brain-computer interface (BCI) that can be implanted directly into the skull. The company’s vision is to empower patients with disabilities to move, communicate, and potentially see again by transmitting neural signals from the brain to external devices like computers and smartphones.
Alongside its work on Blindsight, Neuralink is also testing another implant designed to help paralysed patients regain the ability to control digital devices using only their thoughts. The trial for this implant, expected to take several years, is currently enrolling three participants, according to information available on the U.S. government’s clinical trials database.
Earlier this year, Neuralink successfully implanted chip in its patient, who has since been using the interface to play video games and learn 3D design.