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HealthNeuralink

Elon Musk’s futuristic brain-chip startup Neuralink gets FDA approval for human testing that it says ‘represents an important first step’

By
Verne Kopytoff
Verne Kopytoff
Senior Editor, Tech
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By
Verne Kopytoff
Verne Kopytoff
Senior Editor, Tech
Down Arrow Button Icon
May 25, 2023, 7:35 PM ET
Elon Musk's Neuralink brain-chip startup has FDA approval for a human test.
Elon Musk's Neuralink brain-chip startup has FDA approval for a human test. Jonathan Raa/NurPhoto via Getty Images

Elon Musk’s futuristic brain-chip startup Neuralink has received federal approval for its first in-human clinical trial, marking a major milestone for the company with huge ambitions.

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The company announced the approval by the Food and Drug Administration on Thursday, saying in a tweet that it “represents an important first step that will one day allow our technology to help many people.”

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

Musk has pitched Neuralink’s technology as potentially helping people who suffer from paralysis. The technology involves implanting tiny chips inside people’s skulls to relay electrical signals from the brain to a computer.

Neuralink did not reveal the nature of the FDA’s approval or when a clinical trial would begin. It merely said: “Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”

Neuralink is playing catch-up with competitors. A rival company, Synchron, received approval for a similar trial in 2021.

Musk unveiled Neuralink to the public during a splashy livestreamed event in 2020 during which he showed off pigs that had brain-chip implants walking on a treadmill and nosing around in a pen. He showed off data collected wirelessly from the chips representing the firing of the pigs’ neurons and how the information could be used to predict the position of the pig’s joints.

But behind the scenes, Musk’s company has been stymied by disagreements and executive departures, according to earlier Fortune reporting.

The Fortune 500 Innovation Forum will convene Fortune 500 executives, U.S. policy officials, top founders, and thought leaders to help define what’s next for the American economy, Nov. 16-17 in Detroit. Apply here.
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By Verne KopytoffSenior Editor, Tech
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Verne Kopytoff is a senior editor at Fortune overseeing trends in the tech industry. 

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