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A Bid by Elon Musk to Implant Chips into Human Brains has been Rejected by the FDA

March 4, 2023
minute read

Musk, CEO of Neuralink, requested permission last year to implant brain chips during human testing, but the Biden administration turned him down.

According to Musk's company, which has been using monkeys as test subjects for years, placing chips in human brains would help enhance the treatment of diseases including blindness and paralysis.

Nonetheless, the United States. According to Reuters, the Food and Drug Administration rejected Neuralink's proposal to begin implanting chips into human brains due to safety concerns.

Staff members stated that in explaining the decision to Neuralink, the agency listed hundreds of concerns that the business must resolve before human testing, a crucial step on the way to ultimate product clearance.

The implant's lithium battery, the potential for the tiny wires to spread to other parts of the brain, and concerns over whether and how the device could be removed without harming brain tissue were the agency's main safety concerns, according to current and former Neuralink employees who spoke to Reuters.

According to reports, Neuralink has been working hard to allay the FDA's worries, but existing employees told Reuters they had their doubts about the company's ability to do so quickly.

Musk informed his staff in November that he believed Neuralink will be successful in getting FDA permission for human trials at some point in the spring.

Musk bragged that the technology was so secure that he would feel comfortable implanting it in his own children.

According to a tweet from Musk in November, "We are now convinced that the Neuralink device is ready for people, thus timing is a function of going through the FDA clearance process.

According to Trade Algo, Neuralink has not provided information on the specifics of its trial application, the FDA's denial, or the scope of the agency's concerns.

It is not necessary to report such regulatory contacts to investors as it is a private corporation.

Musk said, without elaborating, that the business had submitted "most of our documentation" to the FDA during the lengthy presentation in November, and Neuralink representatives admitted that the FDA had questioned the company's safety during what they described as an ongoing dialogue.

Musk and other Neuralink officials did not reply to requests for comment on the company’s gadget or its discussions with the FDA.

The FDA declined to comment on Neuralink, citing restrictions keeping commercial information private.

The Post has sought a response from Neuralink and the FDA.

In December, it was revealed that Neuralink was being probed by the authorities for possible breaches of animal welfare rules after personnel protested internally that the brain implants were inflicting needless suffering and deaths.

The US Department of Agriculture's Inspector General launched the federal investigation in the second half of last year at the request of a federal prosecutor.

According to a Trade Algo review of dozens of Neuralink documents and interviews with more than 20 current and former employees, the investigation has been launched at a time of rising employee discontent regarding Neuralink's animal testing, including complaints that pressure from CEO Musk to accelerate development has led to botched experiments.

According to data seen by Trade Algo and people with firsthand knowledge of the organization's animal-testing procedures, since 2018, the company has killed over 1,500 animals, including more than 280 sheep, pigs, and monkeys.

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