Elon Musk’s Neuralink Receives ‘Breakthrough Device’ Status From FDA For ‘Blindsight’ Implant
Elon Musk’s brain chip company Neuralink has been awarded “breakthrough device” status for an implant intended to help blind patients regain their sight, the company announced.
The experimental brain implant, dubbed “Blindsight,” has been cleared by the U.S. Food and Drug Administration to participate in the voluntary program. It is one of 58 devices that have received the designation so far this year, according to the FDA.
Musk, known for making bold claims 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 wore a futuristic visor to see.
“Neuralink’s Blindsight device will allow even those who have lost both eyes and the optic nerve to see” Musk wrote in X On Tuesday, “provided the visual cortex is intact, it will allow even people who have been blind since birth to see for the first time.”
The “breakthrough devices” program aims to “accelerate the development, evaluation and review for premarket approval” of medical devices that treat life-threatening or permanent conditions, provided they meet safety standards, according to the agency’s website.
“To set expectations right, the vision will initially be low-resolution, like Atari graphics, but over time it will have the potential to be better than natural vision and allow you to see in infrared, ultraviolet, or even radar wavelengths, like Geordi La Forge,” Musk added.
Asked for comment, an FDA spokesperson said the designation “does not mean that the device has been found to be safe and effective or that it can be marketed for medical purposes.”
“The FDA only evaluates whether there is a reasonable expectation that a device may provide a more effective treatment or diagnosis relative to the current standard of care in the U.S. for a life-threatening condition or an irreversibly debilitating human disease or condition, and when a device represents a novel technology and there is no legally marketed alternative,” the spokesperson added.
Musk co-founded Neuralink in 2016. It is one of many projects by the tech giant, who also owns X and artificial intelligence startup xAI, in addition to 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, surf 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 in a second human patient.
Although brain chips are considered a long way off from widespread use, Musk has expressed confidence in their safety for years.
In December 2022, Musk said he would be “comfortable” implanting one of the chips into the brains of his own children.
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