Neuralink’s Blindsight Granted FDA Breakthrough Device Designation

Neuralink’s Blindsight Granted FDA Breakthrough Device Designation

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Neuralink, a startup focusing on developing brain-computer interface (BCI) implants, has received the FDA’s breakthrough device designation for Blindsight, a high-tech experimental implant developed to restore vision to people with total loss of sight.

Blindsight is designed to send a microelectrode array into the visual cortex, the part of the brain responsible for receiving, segmenting, and integrating visual information from the retinas so that people can perceive images.

The array provides a visual image by activating the person’s neurons and allowing the user to perceive images in real time.

Founded in 2016 by Elon Musk and a team of seven engineers and scientists: Max Hodak, Dongjin Seo, Benjamin Rapoport, Paul Merolla, Tim Gardner, Tim Hanson, Vanessa Tolosa, and Philip Sabes, Neuralink has developed multiple computer-brain interfaces, with Blindsight being among the most notable devices.

Restoring Vision through BCI

With more than a million Americans classified as blind according to the Center for Disease Control and Prevention (CDC), Blindsight could unlock a new era of vision possibility, helping those who have lost sight to see again.

According to a post shared by Musk on X, Neuralink’s Blindsight could help those who have lost sight in their eyes and optic nerves see again, provided they have their visual cortex intact. As such, even those born blind could see for the first time using the implant.

Musk added that the initial visual details will be a low resolution “like Atari graphics” with the ability to be improved over time, allowing users to see in ultraviolet, infrared, or even in radar wavelengths “like Geordi La Forge.”

Last year, Neuralink secured FDA authorization to move its BCI implants from animals to humans, allowing for its first successful device implant on the first human earlier this year. The patient has since used the company’s implant for various activities, including playing online chess and video games.

The neurotechnology company is currently seeking participants for its PRIME study, which aims to enable participants to control digital devices by thinking through the BCI implant.