Elon Musk's brain-chip startup Neuralink has received FDA breakthrough device designation for Blindsight, an implant that aims to restore vision in individuals who are blind.
According to Musk, the device, called “Blindsight,” will allow people who have lost both eyes and their optic nerve to see as long as the visual cortex — the part of the brain that receives and processes visual information relayed from the eyes— is intact.
“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” Musk wrote on X on Tuesday. “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”
The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices currently under development, reports New York Post.
According to the agency's website, the "breakthrough device" program aims to "speed up development, assessment and review for premarket approval" for medical devices that treat permanent or life-threatening illnesses, provided that they follow safety criteria.
“To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge,” Musk added.
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Neuralink is developing a brain chip interface that can be implanted inside the skull. Founded in 2016 by Musk and a team of engineers, the company claims that this technology might eventually let crippled patients move and speak again as well as restore their vision.
The device from Neuralink contains a chip that can process and send neural signals to other devices, such as a phone or computer.
Earlier this year, Neuralink completed its first successful device implantation in a patient, who has since used the company's BCI for various applications, including playing video games and online chess.
Last year, the company received FDA approval to move from animal and human testing of its BCI device.