The US Food and Drug Administration (FDA) has awarded a Breakthrough Device Designation to Neuralink’s latest brain implant device, Blindsight. This designation is given to medical devices that hold the potential to offer substantial improvements over existing treatments for life-threatening or debilitating conditions.
According to Neuralink, Blindsight aims to restore vision to those who are blind, even to individuals who have lost both eyes or their optic nerves. The implant works by interfacing directly with the brain’s visual cortex. For patients who have lost the ability to see due to injury or disease affecting their eyes or optic nerves, Blindsight bypasses these pathways, delivering information straight to the brain.
This device could even allow people born blind to see for the first time, provided their visual cortex is still functional, Elon Musk explained in a post on X thanking the FDA for the designation.
Initially, the vision provided by Blindsight will be simple. The first patients to receive the implant may experience low-resolution vision, like that of the pixelated graphics of an old Atari video game. However, with continued development, Blindsight could surpass the capabilities of natural vision.
Musk even hinted at the possibility of expanding the device’s functions to provide vision in wavelengths humans typically cannot see, such as infrared, ultraviolet, and even radar. Musk likened this ability to the character Geordi La Forge from Star Trek, who was born blind but with a futuristic visor could see light in infrared and ultraviolet.
Neuralink has not provided a specific timeline for when Blindsight will enter human trials, but the FDA’s designation represents a key milestone that will help further its development.
Neuralink is currently running human trials of their first brain implant, which gives people the ability to control a mouse on a computer screen, or play video games like Mario Kart, purely with thought.
We have received Breakthrough Device Designation from the FDA for Blindsight.
— Neuralink (@neuralink) September 17, 2024
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