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N.Elon Musk’s brain implant company, Euralink, has announced that it has received approval from the U.S. Food and Drug Administration to conduct human clinical trials.
“This is the result of a great job by the Neuralink team working closely with the FDA and is an important first step to one day enabling our technology to help many people,” the company said in a tweet Thursday. .
The FDA and Neuralink did not respond to requests for comment.
Musk’s startup is developing a tiny device consisting of wires wired with electrodes that connects the brain to a computer. A hole must be drilled into the skull to place the device.
Christine Well, a former FDA employee and associate professor of neurosurgery and physiology at the University of Colorado, said the approval was “a really big deal.” “We can start clinical trials in humans, which means we have passed preclinical and bench trials for safety,” she said. This means testing for mechanical and design defects as well as longevity and biocompatibility.
Founded in 2016, Neuralink attracted top neuroscientists working on brain implant research, but many have since moved on to other companies and academia. Musk, who also runs automaker Tesla and owns the social network Twitter, has long said it was nearing FDA approval for human testing.
The company’s device aims to enable people with paralysis and traumatic brain injuries to communicate and control computers using only their thoughts. Ultimately, Musk hypothesized that, beyond helping sick people, the device could help humans keep up with advances made by artificial intelligence.
Neuralink is not the first brain-computer interface company to enter human clinical trials. Since its inception, the field has become increasingly competitive. Syncron, for example, has already enrolled the first patient in a clinical trial in the United States, and its implants are on the road to regulatory approval for widespread use in people with paralysis. Synchron’s device is less invasive than Neuralink’s and works using a different technology.
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Musk’s startup has warned some animal rights groups about experiments on primates. The U.S. Department of Transportation issued a statement after an animal rights group said it had received emails suggesting the startup did not follow proper procedures when shipping potentially hazardous materials. started an investigation.
Despite FDA clinical trial approval, widespread use of brain transplants is not yet imminent. Well said it will likely still be at least five to 10 years before Neuralink’s devices become viable. Preparing a trial and recruiting patients takes months. It took almost a year for Syncron to actually implant the device in July 2022 after it announced it had received FDA approval for its first patient in the United States. Initial human trials typically enroll five to 10 patients and take about six months, Were said.
The first-ever human study allowed the company to adapt its device design accordingly without having to redo the entire FDA submission process. “It gives you flexibility,” says Well.
If the research goes well, Neuralink will initiate what it calls a feasibility study, and finally the critical research. This is much like a Phase 3 study of a drug.
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