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Elon Musk’s Neuralink says it has FDA approval for human trials

Neuralink, Elon Musk’s brain-implant company, said Thursday evening that it has regulatory approval to conduct the first clinical trial of its experimental device in humans.

Approval by the U.S. Food and Drug Administration would mark a milestone for the company, which has been developing a device surgically inserted into the brain by a robot and capable of decoding brain activity and linking it to computers. Up until now, the company has conducted research only in animals.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” Neuralink announced on Twitter, calling it “an important first step that one day will allow our technology to help many people.” Musk retweeted the post, congratulating his team.

Neuralink didn’t immediately respond to a request for comment late Thursday.（本段为发音精讲部分，具体语音讲解请微信关注【可可英语晨读公众号】）

The FDA doesn’t typically confirm approvals for human clinical trials but offered a statement Friday. “The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption … for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” an agency spokesperson said in a statement Friday.

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