Neuralink CEO Elon Musk’s request to implant brain chips in human trials was rejected by the Biden administration last year, according to a report.
Musk’s company, which has been conducting experiments on monkeys for years, claims that implanting chips in human brains 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 start implanting chips into human brains, according to Reuters.
In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path 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 how the device can be removed without damaging brain tissue, current and former Neuralink employees told Reuters.
Neuralink has reportedly been busying working to address the FDA’s concerns, though current staffers told Reuters they were skeptical that the company could resolve the matters within a short period of time.
In November, Musk told his employees that he anticipated Neuralink would be able to secure FDA approval for human trials sometime in the spring.
Musk boasted that the device was so safe he would have no qualms about implanting them in his own children.
“We are now confident that the Neuralink device is ready 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, according to Reuters.
As a private company, it is not required to disclose such regulatory interactions to investors.
During the hours-long November presentation, Musk said the company 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 characterized as an ongoing conversation.
Musk and other Neuralink officials did not respond to requests for comment on the company’s device or its dealings with the FDA.
The agency declined to comment on Neuralink, citing laws keeping commercial 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 needless suffering and deaths.
The federal probe 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 has come at a time of growing employee dissent about Neuralink’s animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees
In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company’s animal-testing operations.
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