Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients regain sight, the firm announced.
Called “Blindsight,” the experimental brain implant received approval 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 statements 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, the character whose Geordi La Forge used a futuristic. ruler to see.
“The Blindsight device from Neuralink will enable those who have lost both their 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 since birth to see for the first time.”
The “breakthrough device” program aims to “accelerate development, evaluation and review for premarket approval” for medical devices that treat life-threatening or life-threatening conditions — as long as they meet safety standards, according to the agency’s website .
“To set expectations right, vision will initially be low-resolution, like Atari graphics, but eventually has the potential to be better than natural vision and enable you to see in infrared, ultraviolet or also radar, like Geordi La Forge. added Musk.
When reached for comment, an FDA spokesman said the designation “does not mean that the device has been deemed safe and effective or that it can be marketed for medical purposes.”
“FDA evaluates only if there is a reasonable expectation that a device can provide more effective treatment or diagnosis, compared to the current US standard of care, for a life-threatening condition or irreversible debilitating human disease or condition, and where a device it represents new technology and no legally marketed alternative exists,” the spokesperson added.
Musk co-founded Neuralink in 2016. It’s one of many projects for the tech titan, who also owns X and 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 person to receive a Neuralink implant.
Since the successful surgery, Arbaugh has been able to play video games, surf the Internet, post on social media and move the laptop cursor with his mind.
Last month, Musk said Neuralink had successfully implanted a brain chip in a second human patient.
While brain chips are considered a long way from mainstream use, Musk has expressed confidence in their safety for years.
In December 2022, Musk said he would be “comfortable” inserting one of the chips into his children’s brains.
By postal wire
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