Neuralink has announced that the United States Food and Drug Administration (FDA) has approved the initiation of its first-in-human clinical study.
“We are thrilled to share that we have received FDA approval to initiate our first-in-man clinical study!” The official Neuralink Twitter account wrote on Thursday.(opens in a new tab) “This is the result of incredible work by the Neuralink team working closely with the FDA and represents an important first step that will one day allow our technology to help many people.”
The neurotechnology company is not yet recruiting test subjects and has released no information on what exactly the clinical trial will entail. Even so, fans of Neuralink founder Elon Musk are already chew(opens in a new tab) To(opens in a new tab) THE(opens in a new tab) bit(opens in a new tab) implant questionable experimental technology into their gray matter.
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Neuralink aims to develop implantable devices that will allow people to control computers with their brains, as well as restore vision or mobility to people with disabilities. However, while this may sound exciting to people with disabilities, there are serious concerns about Neuralink’s brain chips.
The FDA reportedly rejected a previous request from Neuralink to begin human trials last year because there were “dozens of issues the company needs to address.” Among them were concerns that the wires could shift and damage the brain, that the brain could be damaged when removing the device, and that there could be potential problems with its lithium battery.
Neuralink is also being investigated for animal welfare violations, with reports of botched experiments resulting in unnecessary suffering and death. This reportedly included cases of surgeons using the wrong surgical tools, implanting Neuralink devices in the wrong places, and implanting the wrong size devices.
Mashable has contacted the FDA for comment.
Musk has spent years claiming that Neuralink will soon begin human trials. If that latest announcement is true, it could finally happen this time.