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"Even Congenitally Visually Impaired Can See"…FDA Also Approves Musk's Developed Device

Elon Musk's Neuralink Develops 'Blindsight'
Promotes Vision Restoration for Disabled via Brain-Connected Chip
US FDA Designates as 'Breakthrough Device'... Accelerating Development

Neuralink, a neurotechnology startup founded by Elon Musk, CEO of Tesla, is reportedly developing an experimental device to help restore vision for the visually impaired. On the 18th (local time), the US CNBC reported that "the US Food and Drug Administration (FDA) recently designated Neuralink's developing device 'Blindsight' as a 'breakthrough device'." The FDA designates 'breakthrough devices' to expedite the development and review of devices that aid in the treatment or diagnosis of life-threatening conditions.


"Even Congenitally Visually Impaired Can See"…FDA Also Approves Musk's Developed Device Elon Musk, CEO of Tesla. [Image source=Yonhap News]

Blindsight is a project that uses a chip connected to the brain and electrical signals to promote vision restoration for the visually impaired. On the same day, Musk stated on his X (formerly Twitter), "Using Blindsight, even people who have lost both eyes and optic nerves will be able to see ahead," adding, "If the visual cortex is intact, even those who were congenitally visually impaired will be able to see. In the early stages of development, it will look like low-resolution graphics, but it will gradually surpass natural vision." However, the timing for clinical trials of Blindsight has not been announced.


Neuralink, founded by Musk in 2016, has been developing technology to implant brain-computer interface (BCI) devices into the brain to allow people who have lost the use of their limbs due to physical injury to control various electronic devices. The BCI chip converts brain waves into electrical signals to interact with electronic devices, using fine thread-like electrodes to exchange signals with nerve cells. After being rejected once due to safety concerns, it received clinical trial approval from the US Food and Drug Administration (FDA) in September last year.


Earlier this year, Neuralink announced that Nolan Arbo (29), a patient paralyzed from a diving accident, underwent BCI chip ‘N1’ implantation surgery and, within a month, was able to synchronize his intention (brain waves) with cursor movement. In a live-streamed video by Neuralink in March, this man controlled a laptop cursor with his gaze without moving his hands and played online chess. In July, another paralyzed patient, Alex, also underwent implantation surgery, and recently, Alex was featured using only his thoughts to play a first-person shooter video game and operate design software, attracting significant attention.


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