northeuralink Corp., Elon Musk’s brain implant company, said it has received approval from the US 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 said Thursday in a tweet.
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 with electrodes. Device placement requires drilling into the skull.
The approval “is a really big deal,” said Cristin Welle, a former FDA official and associate professor of neurosurgery and physiology at the University of Colorado. “They can start human trials, which means they have passed preclinical safety tests and bench tests,” she said, which means tests for mechanical and design failure, as well as longevity and biocompatibility.
Founded in 2016, Neuralink attracted some of the best neuroscientists to work on its brain implant, though many have since moved on to other companies or academic institutions. Musk, who also runs automaker Tesla and owns the social network Twitter, has said for years that the company was close to winning FDA approval for human trials.
The company’s device aims to help people with paralysis or traumatic brain injury to communicate with and control a computer using only their thoughts. Eventually, in addition to helping sick people, Musk has hypothesized that the device could allow humanity to keep up with advances made by artificial intelligence.
Neuralink is not the first brain-computer interface company to participate in human trials. The field has become competitive since the founding of the company. For example, Synchron has already enrolled its first US patient in a clinical trial, putting the company’s implant on the path to possible regulatory approval for broader use in people with paralysis. Synchron’s device is less invasive than Neuralink’s and works with different technology.
Musk’s startup has sounded alarm bells with some animal rights groups over its tests on primates. The US Department of Transportation launched an investigation into the company after an animal advocacy group said it received emails suggesting the startup failed to follow proper procedure when shipping potentially hazardous materials.
Despite FDA approval of the trial, widespread brain implants are not yet imminent. Neuralink’s device is likely still at least five to 10 years from commercialization, Welle said. Setting up a trial and recruiting patients will take several months. It took Synchron nearly a year between the announcement that it had received FDA approval for its first US patient and the implantation of the device in July 2022. Typically, the first human trials include five to 10 patients and take about six months, Welle said.
The first-in-human study allows the company to tailor its device design based on the results, without having to start the entire FDA application process all over again. “It gives you flexibility,” Welle said.
If the study goes well, Neuralink can begin what is known as a feasibility study and eventually a pivotal study, which is more or less analogous to a Phase III study for a drug.
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