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Home » Neuralink wins FDA breakthrough nod for vision-restoring implant

Neuralink wins FDA breakthrough nod for vision-restoring implant

September 18, 2024 By Sean Whooley

Adobe Stock Image of an eye from Pixel-Shot for Neuralink Brightsight article
Stock image of an eye. [Image licensed from Pixel-Shot on Adobe Stock Images]
Neuralink announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant.

On the social media platform X (formerly Twitter), the Elon Musk-backed brain-computer interface (BCI) venture wrote:

“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.”

Musk, who also owns the X platform, quoted Neuralink’s post to elaborate. He said the Blindsight device “will enable even those who have lost both eyes and their optic nerve to see.”

“Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time,” Musk wrote. “To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge. Much appreciated, FDA!”

Neuralink doesn’t offer much detail on the Blindsight system and how it works or if it’s related to the company’s first BCI offering, Telepathy. The company completed the first human implant of its BCI in January. A nine-minute livestream demonstration showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online. The company also shared plans for another human implant this past summer.

The remotely rechargeable implant goes along with electrode-laced threads that go further into the brain. The company also has an R1 robot designed to implant the BCI system while avoiding vasculature.

(Learn more about BCIs and some of the players in the space here.)

Filed Under: Brain-Computer Interface (BCI), Featured, Health Technology, Implants, Neurological, Optical/Ophthalmic, Vision Tagged With: FDA, neuralink

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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