N:Euralink Corp., Elon Musk’s brain implant company, said it has received approval from the U.S. Food and Drug Administration to conduct human clinical trials.
“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,” the company tweeted Thursday.
The FDA and Neuralink did not immediately respond to requests for comment.
Musk’s startup is developing a small device that will connect the brain to a computer, consisting of wires connected by electrodes. Insertion of the device requires drilling into the skull.
Approval is “a really big deal,” says Christine Welle, a former FDA official and associate professor of neurosurgery and physiology at the University of Colorado. “They can initiate human trials, which means they’ve gone through preclinical safety testing and bench testing,” he said, which means testing for mechanical and design flaws, as well as durability and biocompatibility.
Founded in 2016, Neuralink attracted some of the top neuroscientists to work on its brain implant, though many have since moved on to other companies or academia. Musk, who also runs Tesla and owns the social network Twitter, has said for years that the company is close to FDA approval for human trials.
The company’s device aims to help people with paralysis or traumatic brain injuries communicate and control a computer using only their thoughts. After all, in addition to helping sick people, Musk suggested that the device could enable humanity to follow the progress of artificial intelligence.
Neuralink isn’t the first brain-computer interface company to get into human trials. Since the company’s inception, the industry has become competitive. For example, Synchron has already enrolled its first US patient in clinical trials, putting the company’s implant on the path to possible regulatory approval for wider use in people with paralysis. Synchron’s device is less invasive than Neuralink and uses a different technology.
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Musk’s startup has drawn alarm from some animal rights groups for its experiments on primates. The US Department of Transportation launched an investigation into the company after an animal rights group said it received emails suggesting the startup did not follow proper procedure when shipping potentially hazardous materials.
Despite FDA trial approval, widespread adoption of brain implants is not yet imminent. Neuralink’s device is likely at least five to 10 years away from commercialization, Welle said. The trials will take several months to set up and recruit patients. It took Synchron almost a year to announce that it had received FDA approval for its first US patient and to actually implant the device in July 2022. Typically, first-human trials involve five to 10 patients and last about six months, Welle said.
The first-in-human study allows the company to adjust its device design depending on the results without starting the entire FDA application process over. “It gives you flexibility,” Vele said.
If the study goes well, Neuralink can begin what’s known as a feasibility study, and eventually a pivotal study, roughly similar to a Phase III study of the drug.
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