Elon Musk’s brain-chip startup, Neuralink, has received the U.S. Food and Drug Administration’s “breakthrough device” designation for its experimental implant, Blindsight.
The Blindsight device is designed to restore vision in people with complete or partial blindness, including those with non-functional optic nerves.
“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. Apply to our Patient Registry and openings on our career page,” Neuralink announced on its X (formerly Twitter) page on Tuesday.
The FDA grants this designation to medical devices that treat or diagnose life-threatening conditions, facilitating their development and review process, according to Reuters.
Musk also shared the news on his X platform, emphasizing Blindsight’s potential to restore vision even in the most severe cases of blindness.
“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerves to see. If the visual cortex is intact, it will allow individuals who have been blind from birth to see for the first time. Initially, the vision will be low resolution, like Atari graphics, but it has the potential to surpass natural vision, allowing users to see in infrared, ultraviolet, or even radar wavelengths, like Geordi La Forge,” Musk wrote.
Neuralink, co-founded by Musk in 2016, focuses on developing advanced brain-computer interfaces to revolutionize treatments for neurological conditions.
The company’s technology includes a brain implant that reads neural signals and wirelessly transmits them to external devices such as computers and mobile devices. Neuralink is also working on an implant that enables paralyzed individuals to control digital devices using only their thoughts.
Business World reports that Neuralink is conducting a clinical trial with three participants to evaluate the implant’s effectiveness in assisting those with spinal cord injuries. In August 2024, it was widely reported that Neuralink successfully implanted its brain-computer interface in a second patient, who is now controlling video games and creating 3D designs solely with their thoughts.