Elon Musk's brain implant company Neuralink says the FDA has approved human trials

2025-04-28 09:37:09admin

Neuralink has announced that the U.S. Food and Drug Administration (FDA) has approved the launch of its first clinical study in humans.

"We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!" Neuralink's official Twitter account wrote on Thursday. "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."

SEE ALSO: Elon Musk's Neuralink is reportedly under investigation for animal welfare violations

The FDA confirmed Neuralink's announcement in a statement to Mashable.

"The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption (IDE) for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device," said an FDA spokesperson.

R1 is a surgical robot designed to implant the neurotechnology company's brain chips.

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Neuralink isn't recruiting test subjects just yet, and hasn't released any information on exactly what the clinical trial will involve. Even so, fans of Neuralink founder Elon Musk are already chomping at the bit to implant questionable experimental technology in their grey matter.

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Neuralink aims to develop implantable devices that will let people control computers with their brain, as well as restore vision or mobility to people with disabilities. However, while this may sound exciting for people with disabilities, there are serious concerns about Neuralink's brain chips.

The FDA reportedly rejected a previous application from Neuralink to begin human trials last year, as there were "dozens of issues the company must address." Among them were concerns that wires could shift and damage the brain, that the brain might be damaged during removal of the device, and that there may be potential issues with its lithium battery.