Neuralink CEO Elon Musk’s request to implant brain chips in human trials was rejected by the Biden administration last yr, in line with a report.
Musk’s company, which has been conducting experiments on monkeys for years, claims that implanting chips in human brains will result in advances in curing conditions reminiscent of blindness and paralysis.
However the Food and Drug Administration flagged safety concerns in rejecting Neuralink’s application to begin implanting chips into human brains, in line with Reuters.
In explaining the choice to Neuralink, the agency outlined dozens of issues the corporate must address before human testing, a critical milestone on the trail to final product approval, staffers said.
The agency’s major safety concerns involved the device’s lithium battery, the potential for the implant’s tiny wires to migrate to other areas of the brain, and questions over whether and the way the device will be removed without damaging brain tissue, current and former Neuralink employees told Reuters.
Neuralink has reportedly been busying working to handle the FDA’s concerns, though current staffers told Reuters they were skeptical that the corporate could resolve the matters inside a brief time frame.
In November, Musk told his employees that he anticipated Neuralink would give you the chance to secure FDA approval for human trials sometime within the spring.
Musk boasted that the device was so protected he would don’t have any qualms about implanting them in his own 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 has not disclosed details of its trial application, the FDA’s rejection or the extent of the agency’s concerns, in line with Reuters.
As a non-public company, it will not be required to reveal such regulatory interactions to investors.
Through the hours-long November presentation, Musk said the corporate had submitted “most of our paperwork” to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterised as an ongoing conversation.
Musk and other Neuralink officials didn’t reply to requests for comment on the corporate’s device or its dealings with the FDA.
The agency declined to comment on Neuralink, citing laws keeping industrial information private.
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 staffers complained internally that the brain implants were causing unnecessary suffering and deaths.
The federal probe was opened within the latter half of last yr by the US Department of Agriculture’s Inspector General on the request of a federal prosecutor.
The investigation has come at a time of growing worker dissent about Neuralink’s animal testing, including complaints that pressure from CEO Musk to speed up development has resulted in botched experiments, in line with a Reuters review of dozens of Neuralink documents and interviews with greater than 20 current and former employees
In all, the corporate has killed about 1,500 animals, including greater than 280 sheep, pigs and monkeys, following experiments since 2018, in line with records reviewed by Reuters and sources with direct knowledge of the corporate’s animal-testing operations.
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