Elon Musk's Neuralink gains FDA breakthrough tag for vision implant

Neuralink's vision-restoring device, named Blindsight, is designed to allow even individuals who have lost both eyes and their optic nerves to regain sight

Elon Musk’s brain-chip company, Neuralink, announced on Tuesday that its experimental implant designed to restore vision has received the US Food and Drug Administration’s (FDA) ‘breakthrough device’ designation. This significant milestone marks a crucial step forward in the development of Neuralink’s cutting-edge technology aimed at treating severe medical conditions.

The FDA awards the breakthrough device designation to medical innovations that provide diagnosis or treatment for life-threatening or irreversibly debilitating conditions. The goal is to accelerate the development and review process of these devices, offering hope for patients facing limited treatment options.

Neuralink’s vision-restoring device, named Blindsight, is designed to allow individuals who have lost both eyes and their optic nerves to regain sight. Musk, in a post on social platform X (formerly Twitter), said Blindsight “will enable even those who have lost both eyes and their optic nerve to see.”

 

The Blindsight device from Neuralink 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.

To set expectations correctly, the vision… https://t.co/MYLHNcPrw6 pic.twitter.com/RAenDpd3fx

— Elon Musk (@elonmusk) September 17, 2024

However, the company has yet to disclose when Blindsight will enter human trials, and the FDA has not provided further comment.

Founded by Musk and a team of engineers in 2016, Neuralink is developing a brain-chip interface that can be implanted within the skull. The company claims this technology has the potential to help patients with disabilities move, communicate, and now, restore their vision. The chip processes and transmits neural signals, which can be sent to external devices like computers or smartphones.

Mind control tech advances

In parallel, Neuralink is testing another implant aimed at giving paralysed patients the ability to control digital devices using their thoughts. This innovative technology could be transformative for those with spinal cord injuries. A trial is set to evaluate the device’s effectiveness with three patients over several years, according to the US government’s clinical trials database.

Earlier this year, Neuralink successfully implanted its brain-chip in a second patient, who is now using it to play video games and learn 3D design — offering a glimpse into the future of brain-computer interfaces.

[With agency inputs]