Neuralink, Elon Musk’s brain-computer interface (BCI) venture, said its experimental Blindsight implant has been granted the breakthrough device designation by the US Food and Drug Administration (FDA).
Blindsight is designed to restore vision in people who have lost it.
On the social media platform X (formerly Twitter), the BCI venture announced: “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 quoted Neuralink’s post to add details, stating that the Blindsight device “will enable even those who have lost both eyes and their optic nerve to see.”
He added: “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”
Musk emphasised that while initial vision may be low resolution, comparable to Atari graphics, it can surpass natural vision, allowing users to see in infrared, ultraviolet, or even radar wavelengths.
Neuralink has not provided many details about the Blindsight system, including its functionality or its relationship to the company’s first BCI offering, Telepathy.
Founded in 2016 by Elon Musk and a team of engineers, Neuralink is developing a brain chip interface that can be implanted in the skull.
The company aims to help disabled patients regain movement and communication abilities, as well as restore vision.
Additionally, Neuralink is conducting tests on an implant designed to allow paralysed patients to control digital devices through thought alone.
In January, the startup completed its first human implant of a BCI, showcasing a nine-minute livestream where Noland Arbaugh used the device to control a computer cursor and play chess online.
In August, the venture successfully implanted its BCI in a second patient who had a spinal cord injury and was paralysed in a diving accident.
The second patient’s surgery was part of Neuralink’s ongoing clinical trials, which aim to implant its BCI device in eight additional patients within the year.
This summer, the company also announced plans for another human implant.
The brain-chip startup has also developed an R1 robot designed to implant the BCI while avoiding blood vessels.
