Elon Musk’s Neuralink has announced that it received “breakthrough device” clearance from the U.S. Food and Drug Administration.
An FDA breakthrough device is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The billionaire claimed on X that the product called Blindsight, “will enable even those who have lost both eyes and their optic nerve to see,” provided the visual cortex is intact.
He added that “it will even enable those who have been blind from birth to see for the first time.”
The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.
Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.
To set expectations correctly, the vision… https://t.co/MYLHNcPrw6 pic.twitter.com/RAenDpd3fx
— Elon Musk (@elonmusk) September 17, 2024
However, this does not mean the brain chip startup has developed a cure for blindness, as it remains in the early stages and the process is complex. While it did not specify a timeline for human trials, the designation allows for an expedited review by the FDA, potentially paving the way for human testing.
We have received Breakthrough Device Designation from the FDA for Blindsight.
Join us in our quest to bring back sight to those who have lost it. Apply to our Patient Registry and openings on our career page https://t.co/abBMTdv7Rh
— Neuralink (@neuralink) September 17, 2024
What is Neuralink’s Blindsight?
Blindsight is said to work by bypassing damaged optic nerves and directly stimulating the visual cortex with a microelectrode array, the area of the brain responsible for processing visual information.
Musk compared its early-stage vision quality to the graphics of vintage video games like those produced by Atari. In March, the Tesla CEO stated that the chip had already been used on monkeys and that it was working.
I should mention that the Blindsight implant is already working in monkeys.
Resolution will be low at first, like early Nintendo graphics, but ultimately may exceed normal human vision.
(Also, no monkey has died or been seriously injured by a Neuralink device!)
— Elon Musk (@elonmusk) March 21, 2024
University of Washington Psychology Professors Ione Fine and Geoffrey Boynton have been skeptical about the device. Writing for The Conversation, they state that Musk’s assertion that neurons in the brain are like pixels on a screen is a “fallacy.”
The pair created a computational model of human vision to simulate what sort of vision an extremely high-resolution cortical implant might provide. A movie of a cat with a resolution of 45,000 pixels versus one generated using a simplified version of a model of 45,000 cortical electrode, showed a fairly blurry image.
ReadWrite has reached out to Neuralink for comment.
Featured image: Ideogram
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