Neuralink CEO Elon Musk’s request to implant brain chips in human trials was denied by the Biden administration last yr, according to the report.
Musk’s company, which has been conducting experiments on monkeys for years, claims that implanting chips into human brains will lead to advances within the treatment of diseases equivalent to blindness and paralysis.
However the Food and Drug Administration has raised safety concerns rejecting Neuralink’s application to start implanting chips into human brains, according to Reuters.
Explaining Neuralink’s decision, the agency outlined dozens of issues the corporate needs to address ahead of human testing, a key milestone on the road to final product approval, employees said.
The agency’s important safety concerns were the device’s lithium battery, the potential of the implant’s tiny wires migrating to other areas of the brain, and questions on whether and the way the device might be removed without damaging brain tissue, current and former Neuralink employees told Reuters.
![In November, Elon Musk told his employees at Neuralink that he expected FDA approval this spring.](https://nypost.com/wp-content/uploads/sites/2/2023/03/NYPICHPDPICT000006435827.jpg?w=1024)
Reportedly, Neuralink was busy working to solve the FDA’s problems, although current employees told Reuters they were skeptical that the corporate could solve the issues within the short term.
In November, Musk told his employees that he expected Neuralink to find a way to get FDA approval for human trials within the spring.
Musk boasted that the device was so protected that he would haven’t any qualms about implanting it in his children.
“We are actually confident that the Neuralink device is prepared for humans, so timing is a function of working through the FDA approval process,” Musk tweeted in November.
Neuralink didn’t disclose details of its trial application, FDA rejection, or the extent of the agency’s concerns, according to Reuters.
As a personal company, now we have no obligation to disclose such regulatory interactions to investors.
In the course of the hours-long November presentation, Musk said the corporate had submitted “most of our documents” to the agency without specifying any formal application, and Neuralink officials confirmed the FDA had raised safety questions in what they characterised as an ongoing conversation.
Musk and other Neuralink officials didn’t respond to requests for comment in regards to the company’s device or its dealings with the FDA.
The agency declined to comment on Neuralink, citing laws that make sure the privacy of economic information.
The Post has sought comment from Neuralink and the FDA.
![Neuralink is under investigation by the federal government for alleged animal welfare violations related to the company's experiments on monkeys and other animals.](https://nypost.com/wp-content/uploads/sites/2/2023/03/NYPICHPDPICT000003668545.jpg?w=1024)
In December, it was reported that Neuralink was under investigation by federal authorities for alleged violations of animal welfare laws after employees complained internally that brain implants caused unnecessary suffering and death.
The federal investigation was initiated within the second half of last yr by the Inspector General of the US Department of Agriculture on the request of the federal prosecutor.
The investigation began amid growing worker opposition to Neuralink animal testing, including complaints that pressure from CEO Musk to speed up development led to failed experiments, according to a review of dozens of Neuralink documents and interviews with greater than 20 present and were employees
In total, the corporate has killed around 1,500 animals, including greater than 280 sheep, pigs and monkeys, after experiments since 2018.
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