Elon Musk’s brain-chip startup, Neuralink, has received the US Food and Drug Administration’s (FDA) “breakthrough device” designation for its experimental vision-restoring implant, Blindsight.
This device is designed to help individuals with complete or partial blindness, including those with non-functional optic nerves.
Neuralink announced the milestone on its X (formerly Twitter) page, stating, “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.”
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The FDA grants its breakthrough designation to devices addressing life-threatening or debilitating conditions, aiming to expedite development and review.
According to Musk, the Blindsight device holds the potential to restore vision even for those who have lost both eyes and their optic nerve.
“Provided the visual cortex is intact, it will enable those who have been blind from birth to see for the first time,” Musk shared on his X platform.
He added that while initial vision may resemble “low resolution, like Atari graphics,” the technology could eventually surpass natural vision and expand to seeing infrared, ultraviolet, or radar wavelengths.
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Neuralink, founded in 2016, is pioneering brain-computer interface technology aimed at treating neurological conditions. In addition to vision restoration, the company is developing implants that allow paralyzed individuals to control digital devices using their thoughts.
The company is currently conducting a clinical trial with three participants to assess its technology for spinal cord injuries.
It was reported that Neuralink’s brain-computer interface was successfully implanted in a second patient in August 2024, enabling them to control video games and create 3D designs using only their thoughts.
