Neuralink, the brain implant research company owned by billionaire Elon Musk, says it has received U.S. regulatory approval to begin testing its device in humans.
The company said in a tweet Thursday evening that it has received approval from the U.S. Food and Drug Administration to launch its “first-in-human clinical study.”
No details were provided on the potential trial, but Neuralink said information on recruitment for participants will be announced “soon.” As of Friday afternoon, the study did not appear in the U.S. database for clinical trials.
An FDA spokesperson said it acknowledged the company’s announcement, which it called an investigational device exemption, but would neither confirm nor deny that it has granted approval.
Musk, who also owns Twitter, Tesla and Space X, congratulated Neuralink in a tweet of his own.
Thursday’s announcement fits within the timeline Musk laid out in December when he said Neuralink had submitted its application to the FDA with the hopes of being cleared to start human trials in six months.
Until now, Neuralink has been testing its brain computing interface (BCI) product in the brains of animals, including primates and pigs.
The device is about the size of a large coin and is designed to be surgically implanted by a robot in the skull, with ultra-thin wires going directly into the brain. The goal, according to the company, is to allow a person fitted with a BCI to control a piece of technology with their mind.
Musk has said the first two applications in people would be to attempt to restore vision and try to help people with little or no ability to operate their muscles rapidly to use digital devices. He also said he envisions that signals from the brain could be bridged to Neuralink devices in the spinal cord for someone with a broken neck, or to help a paraplegic walk again.
But Musk has also indicated he believes that Neuralink can achieve more, beyond medical applications. In 2021, he revealed footage of what he said was a monkey fitted with a BCI playing a video game “with his mind.”
It’s unclear how well this device or similar interfaces will ultimately work, or how safe they might be. Neuralink’s interface is considered an “investigational device” at this point, and clinical trials are designed to collect data on safety and effectiveness.
Reuters revealed in December that Neuralink is under federal investigation in the U.S. for allegedly rushing its testing in animals, which has resulted in about 1,500 animal deaths, according to documents and sources within the company.
Neuralink is one of many groups working on linking the nervous system to computers, efforts aimed at helping treat brain disorders, overcoming brain injuries and other applications.
Earlier this week, for example, researchers in Switzerland published research in the journal Nature describing an implant that restores communication between the brain and spinal cord to help a man with paralysis to stand and walk naturally. There are more than 30 brain or spine computer interface trials underway, according to clinicaltrials.gov.
— with files from the Associated Press