Neuralink CEO Elon Musk’s request to put brain chips into human trials was rejected by the Biden administration last year, according to a report.
Musk’s company, which has been experimenting with monkeys for years, claims that implanting chips in the human brain will lead to advances in curing conditions such as blindness and paralysis.
But the Food and Drug Administration flagged safety concerns in rejecting Neuralink’s application to begin implanting chips in human brains. According to Reuters.
In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, an important milestone on the path to final product approval, staff said.
The agency’s main safety concerns included questions about the device’s lithium battery, the potential for tiny wires from the implant to travel to other areas of the brain, and whether and how the device could be removed without damaging brain tissue, the current and former Neuralink employees told Reuters. .
Neuralink is reportedly busy working to address the FDA’s concerns, although current staff told Reuters they were skeptical the company could resolve matters in the short term.
In November, Musk told his employees that he hoped Neuralink would be able to get FDA approval for human trials sometime in the spring.
Musk boasted that the device was so safe that he would not hesitate to implant it in his children.
“We are now confident that the Neuralink device is ready for humans, so time is a function of working through the FDA approval process,” Musk tweeted in November.
Neuralink has not disclosed details of its trial application, the FDA’s rejection or the extent of the agency’s concerns, according to Reuters.
As a private company, investors are not required to disclose such regulatory interactions.
During an hours-long November presentation, Musk said the company had submitted “most of our paperwork” to the agency, without a formal application, and NeureLink officials acknowledged that the FDA had raised safety questions. were asked in which they were characterized as ongoing conversations.
Musk and other NeureLink officials did not respond to requests for comment on the company’s device or its deal with the FDA.
The agency declined to comment on Neuralink, citing laws protecting commercial confidentiality.
The Post has sought comment from Neuralink and the FDA.
In December, it was reported that Neuralink was being investigated by the feds for alleged violations of animal welfare laws after staff complained internally that the brain implants were causing unnecessary suffering and death. .
A federal investigation was opened in the latter half of last year by the US Department of Agriculture’s inspector general at the request of a federal prosecutor.
The investigation comes at a time of growing employee dissent about Neuralink’s animal testing, including complaints that pressure from CEO Musk to speed up development has led to frivolous experiments, according to a Reuters review of dozens of Neuralink documents. And according to more than 20 current and interviews. Ex-employee
According to records reviewed by Reuters and sources with direct knowledge of the company’s animal-testing operations, the company has killed a total of about 1,500 animals, including more than 280 sheep, pigs and monkeys, after experiments since 2018. are
With post wire
