In spite of a wave of news reports suggesting that more delays were on the horizon, almost exactly six months after Elon Musk said his neurotech company Neuralink was half a year away from beginning human trials of its flagship brain implant, the company has achieved that goal.
The FDA has greenlit Neuralink’s request to begin in-human studies of the device, the Musk-owned company announced—where else?—on Twitter on Thursday.
“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 tweet continued. “Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”
Neuralink’s brain-computer interface is put in place of a removed piece of skull in a procedure conducted by the company’s own surgical robots. Once in place, it connects to the brain to stimulate both mental and physical activity.
During the early December “show-and-tell” presentation where he set the six-month timeline, Musk outlined the implant’s first two applications. For one, it could restore eyesight—"even if someone has never had vision ever—like, they were born blind,” he said—by stimulating the visual cortex. The device may also improve communication for people with severe paralysis, translating their thoughts into electronic movements to help them “operate their phone faster than someone who has working hands,” per Musk.
Meanwhile, longer-term goals for the technology include connecting all users’ brains to their phones—regardless of medical needs—and helping quadriplegic patients to walk again.
“We’re confident there are no physical limitations to enabling full-body functionality,” the Neuralink founder said during the presentation. “As miraculous as it may sound, we’re confident that it is possible to restore full-body functionality to someone who has a severed spinal cord.”
Neuralink didn’t specify in Thursday’s tweet which of these indications it’ll be studying in the upcoming clinical trials.
The FDA’s trial greenlight arrives several years after Musk first planned to begin testing the implant and comes in the wake of a series of setbacks for the company.
Earlier this year, Reuters reported that Neuralink’s first request to begin human studies of the device had been rejected by the FDA in the spring of 2022; several current and former employees cited in the report expressed doubts that the company would be able to rectify all of the issues pinpointed by the agency in time to meet Musk’s May deadline.
Neuralink is also reportedly currently the subject of an investigation by the U.S. Department of Agriculture’s inspector general over its animal-testing practices. It has been accused of severely mistreating the macaque monkeys it used to test the brain-computer interface, and of allowing dozens more animal subjects to die in its care due to botched experiments allegedly rushed along by Neuralink’s ambitious timelines. The company has denied all allegations of abuse.