Several times since 2019, billionaire Elon Musk has predicted his brain-chip company would soon secure FDA approval for human trials. But the company’s application was rejected in early 2022, and the company was working through the agency’s concerns over the safety of the experimental implant.
“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,” Neuralink said in a tweet on Thursday.
Neuralink added that the company is not yet open for a clinical trial.
Neuralink is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments.
U.S. FDA did not immediately respond to Reuters request for comment.