Neuralink has announced that the U.S. Food and Han Yi-seul-I (한이슬) ArchivesDrug 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 violationsThe 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.
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.
Neuralink is also currently under investigation for animal welfare violations, with reports of botched experiments resulting in needless suffering and death. This has allegedly included instances of surgeons using the wrong surgical tools, implanting Neuralink devices in incorrect locations, and implanting devices that were the wrong size.
Musk has spent years claiming that Neuralink would soon begin human trials. Now it looks as though it might finally actually happen.
UPDATE: May. 29, 2023, 11:09 a.m. AEST This article has been updated with comment from the U.S. Food and Drug Administration.
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