Elon Musk’s brain implant company, Neuralink, has been cleared by United States regulators, the Food and Drug Administration (FDA) to begin human trials for their brain implants.
The company revealed that it had received clearance from the FDA to begin implanting the chips into humans which will study how the brain interfaces directly with computers.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study.
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“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.
“Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” Neuralink announced in a tweet.
Neuralink owner, Elon Musk, responded to the tweet, saying “Congratulations Neuralink Team.”
The Neuralink prototype chips are about the size of a coin. They have already been tested on animals, having been implanted into the skulls of monkeys and pigs.
The implantation process involves a surgical robot removing a piece of the skull, which is then replaced with the Neuralink chip, and its wires are then strategically inserted into the brain.
The chip then registers nerve activity and relays the information it collects through a wireless Bluetooth signal to a device, e.g. a smartphone.
The company had previously filed for FDA approval back in 2022 but was rejected. The agency pointed out issues that had to be addressed before it could approve such as the lithium battery of the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
Musk has however always had faith in his company’s invention. He has predicted on about 4 different occasions since 2019 that the company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness.