San Francisco: Elon Musk-led brain-computer interface company Neuralink on Friday announced that it has received US Food and Drug Administration (FDA) approval to begin its first-in-human clinical study, which means that actual humans could have a Neuralink device implanted in their heads.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study,” Neuralink tweeted.
“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,” it added.
On receiving the FDA approval, Musk also tweeted congratulating the Neuralink team.
Moreover, the company said that the recruitment for the clinical trial is not open yet, and it will announce more information regarding this soon.
In March, the FDA rejected Neuralink’s bid to implant a chip in a human brain over safety risks.
In December last year, Musk had claimed Neuralink’s device is ready for human trials and he is expecting to do so in about six months after experimenting it on pigs and monkeys.
However, Musk’s Neuralink would not be the first to implant a brain-computer interface into humans.
Neuralink rival Synchron launched human trials on six severely paralysed patients in the US to enable them to control digital devices hands-free, using just thoughts last year in May.
The US-based Synchron is an endovascular brain-computer (BCI) interface company that competes with Neuralink, which also aims to enable paralysed people to use computers and phones through their brain activities alone.
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