Neuralink Receives FDA Breakthrough Designation for Vision Restoring Implant

On September 17, Neuralink, the brain-chip startup founded by Elon Musk, announced that its experimental device aimed at restoring vision, even for individuals born blind, has received the U.S. Food and Drug Administration's "breakthrough device" designation. This designation is granted to medical devices that offer significant advancements in treating life-threatening conditions, expediting their development and review processes.

The device, known as Blindsight, is designed to allow individuals who have lost their eyesight, including those without optic nerves, to perceive visual stimuli. Musk stated on social media that the device could enable those who have been blind from birth to see for the first time, provided their visual cortex remains intact.

Initially, the visual output will be low resolution, akin to early video game graphics, but Musk claims the technology has the potential to surpass natural vision and allow perception in various wavelengths, including infrared and ultraviolet.

Neuralink is preparing to move forward with human trials for the Blindsight device. Founded in 2016, the company aims to create brain-computer interfaces that could assist individuals with disabilities, enabling movement, communication, and restoration of vision. The startup is also exploring technology to allow paralyzed patients to control digital devices using only their thoughts.