Elon Musk’s brain-implant startup Neuralink has been approved by the U.S. Food and Drug Administration to begin the company’s first human clinical study, the agency said.
The company is working on a device that will allow people to control computer interfaces with their brains. Neuralink said the devices would help restore vision and enable people with severe disabilities to move and communicate by decoding brain activity.
Neuralink plans to open clinics where surgical robots will implant the devices into the brains of patients. The robot surgeon threads Neuralink’s proprietary electrodes, or brain-signal recording wires, into the brain.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study,” Neuralink said in a tweet. “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 it hasn’t opened recruitment for its trial but will announce more information soon.
Musk said in 2019 that the company planned to apply for FDA approval for human testing. At the time he predicted the approval would be in place as soon as 2020.
Neuralink has tested its implant technology on primates for several years. The company released a video in April 2021 showing a monkey implanted with two Neuralink devices could play a videogame called Pong using only his brain.
During a demonstration in December, Musk showed a video of what he called “telepathic typing” from a monkey with a Neuralink brain implant. The animal used his mind to move a cursor to images of letters during the demonstration.
Clinical testing proving the Neuralink device is safe and effective long-term would be necessary before a brain-computer interface could be introduced to patients, neurotechnology experts have said.
Musk said in December the company was working to address concerns from the FDA regarding overheating of the device and toxic chemicals seeping into the brain from the implant. Neuralink has euthanized several of its monkeys for suspected device-associated infections, the company said in February 2022.
Neuralink said device-associated infections are an inherent risk with any medical device that is implanted through the skin. The company later developed new surgical protocols.
Write to Joseph De Avila at joseph.deavila@wsj.com