On Thursday, Neuralink said in a tweet that the US Food and Drugs Administration had approved it to start its first human clinical study. It added that it had no immediate plans to recruit people for the test.
“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 tweeted.
In December, the brain interface firm said it had applied to the FDA to allow human trials, with the hopes of starting them within the next six months. Weeks later, the company began allowing patients to register their interest to enroll in future tests.
Neuralink’s tech monitors brain activity and can be trained to recognise patterns in that activity, and turn them into actions.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
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…
— Neuralink (@neuralink) May 25, 2023
It has tested prototypes on macaque monkeys, including one called Sake, who was shown during a presentation typing and playing a version of classic video game Pong using the implant.
Last year, the US Department of Agriculture began investigating Neuralink for potential animal welfare violations.
In all, the company has allegedly killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018.
An earlier attempt by Neuralink to win FDA approval was rejected on safety grounds, according to a report in March by the Reuters news agency that cited multiple current and former employees.
Musk initially predicted Neuralink would be in human heads by the end of 2020 in a 2019 statement. In 2021 he predicted trials would start soon.
While his lofty claims are becoming somewhat of a habit, FDA clearance could yield demonstrations of the assistive capabilities of its implants for humans. In the past, Neuralink has been restricted to seeking input from patients and caregivers on product development.
The firm’s announcement of FDA approval follows a major breakthrough in brain implant tech. Earlier this week, Swiss researchers said their brain-spine interface restored a paralysed man’s ability to stand and walk naturally.