Elon Musk’s Neuralink receives FDA’s ‘breakthrough device’ status for ‘Blindsight’ implant
Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients regain their sight, the firm announced.
Dubbed “Blindsight,” the experimental brain implant gained clearance from the US Food and Drug Administration to participate in the voluntary program. It is one of 58 devices to receive the designation so far this year, according to the FDA.
Musk – who is known for making bold proclamations about his companies’ products long before they hit the market – celebrated the FDA’s decision by sharing a photo of “Star Trek: The Next Generation” actor LeVar Burton, whose character Geordi La Forge used a futuristic visor to see.
“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” Musk wrote on X on Tuesday. “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”
The “breakthrough device” program is aimed at “speeding up development, assessment and review for premarket approval” for medical devices that treat life-threatening or permanent conditions – as long as they meet safety standards, according to the agency’s website.
“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,” Musk added.
When reached for comment, an FDA spokesperson said the designation “does not mean the device has been deemed safe and effective or that it can be marketed for medical purposes.”
“The FDA assesses only whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current U.S. standard of care, for a life-threatening condition or irreversibly debilitating human disease or conditions, and where a device represents novel technology and no legally marketed alternative exists,” the spokesperson added.
Musk co-founded Neuralink in 2016. It is one of many projects for the tech titan, who also owns X and the artificial intelligence startup xAI while also serving as CEO of Tesla and SpaceX.
Neuralink is also developing an implant that aims to allow paralyzed patients the ability to use digital devices with their brains.
In January, Noland Arbaugh, a 30-year-old Arizona man who was paralyzed from the neck down after a diving accident, became the first human to receive a Neuralink implant.
Since the successful operation, Arbaugh has been able to play video games, browse the internet, post on social media and move a laptop cursor with his mind.
Last month, Musk said Neuralink had successfully implanted a brain chip into a second human patient.
While the brain chips are considered a long way off from mainstream use, Musk has expressed confidence about their safety for years.
In December 2022, Musk said he would be “comfortable” implanting one of the chips into his own children’s brains.
With Post wires
