Neuralink Blindsight receives FDA Breakthrough Device Designation for visually impaired patients

Neuralink Blindsight receives FDA Breakthrough Device Designation for visually impaired patients

As a gamer who has been blind since birth and relied heavily on my imagination to navigate the vibrant worlds of gaming, the news about Neuralink’s Blindsight technology brings tears of hope to my eyes. I remember countless hours spent playing Civilization 6, listening intently to the game sounds, imagining the landscapes, and strategizing my moves.


Neuralink’s work on brain-interface technology includes a project called Blindsight, designed to restore sight to people who have lost or never had it through innovative medical implant tech. This Blindsight segment of Neuralink has been recognized by the FDA as a Breakthrough Device, signifying significant progress in this field.

This week, Neuralink announced on their social media that they had reached a significant milestone with their Blindsight technology, thanks to the FDA’s designation. According to the FDA’s webpages about Breakthrough Device Designation, this means the FDA will assist in moving Blindsight from development and research stages into patient access. This process includes pre-market approval and 510(k) clearance, which ensures the product is safe and effective for medical use and procedures. Neuralink has now made their patient registry list accessible for those interested in participating in clinical trials for their technologies.

We’ve secured a Breakthrough Device Designation from the FDA for Blindsight – a groundbreaking development! Join us as we strive to restore vision to the visually impaired. Sign up for our Patient Registry and explore employment opportunities on our careers page.

— Neuralink (@neuralink) September 17, 2024

Neuralink Corporation has made some progress in readying their product for human operations. This year, they successfully conducted their first human operation by implanting a quadriplegic patient with their N1 Implant. Remarkably, this individual was then able to play Sid Meier’s Civilization 6 entirely using only brain activity. Since that breakthrough, Neuralink has been refining and upgrading its technology thanks to these experimental trials.

Thanks to the FDA’s Breakthrough Device Designation, Neuralink is poised to make significant strides in developing technology aimed at assisting individuals with visual impairments. Keep an eye out for more news and developments on this topic.

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2024-09-18 00:57