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  • Writer's pictureScott Newell

Milestone Achievement: Elon Musk's Neuralink Approved by FDA for Human Brain Implant Study

Elon Musk's company, Neuralink, has obtained clearance from the U.S. Food and Drug Administration (FDA) for its first-in-human clinical trial, marking a significant achievement for the brain-implant startup. This clearance comes at a crucial time for Neuralink, as it faces investigations in the United States regarding its handling of animal experiments. Neuralink expressed the importance of the FDA approval, stating in a tweet that it represents a crucial initial step toward enabling their technology to assist numerous individuals. While specific details of the planned study were not disclosed, Neuralink mentioned that they are not currently recruiting participants for the trial but will provide more information soon.

In a statement, the FDA confirmed that the company has received clearance to utilize its brain implant and surgical robot for trials involving patients, but further details were not provided.

Neither Neuralink nor Elon Musk responded to requests for comment regarding these developments.

This milestone arrives amidst federal scrutiny stemming from reports about the company's animal experiments. Employees at Neuralink revealed to media outlets last year that the company was hastily conducting surgeries on animals, such as monkeys, pigs, and sheep, resulting in avoidable animal deaths. These sources claimed that the pressure from Musk to obtain FDA approval led to inadequate preparation. The data from these animal experiments was intended to support Neuralink's application for human trials. One incident in 2021 involved the improper implantation of the wrong-sized devices in 25 out of 60 pigs. As a result, all the pigs had to be euthanized, highlighting an error that could have been prevented with better preparation.

The Department of Transportation is conducting an investigation to determine whether Neuralink unlawfully transported hazardous pathogens on chips extracted from monkey brains without implementing appropriate containment measures. Moreover, the U.S. Department of Agriculture's Office of Inspector General is investigating potential animal-welfare violations at Neuralink. This probe focuses on the USDA's oversight of the company.

The launch of these investigations was prompted by concerns expressed by employees, who believe that Neuralink's rush to conduct experiments has led to increased suffering and deaths among animals, including pigs, sheep, and monkeys.

According to FDA records and a Neuralink employee, as of several weeks ago, the FDA had not conducted an inspection of Neuralink's laboratory practices. Victor Krauthamer, an adjunct biomedical engineering professor with extensive experience at the FDA, expressed the opinion that the FDA should have verified the reliability of Neuralink's animal study results given the concerns raised about the animal testing.

Elon Musk envisions that brain implants could offer potential cures for various conditions, including obesity, autism, depression, schizophrenia, and even enable activities such as web browsing and telepathy. He gained attention when he expressed his confidence in the safety of the devices by stating his willingness to have them implanted in his own children. Although Musk had predicted on several occasions since 2019 that Neuralink would commence human trials, the company only sought FDA approval in early 2022, with their application subsequently rejected by the agency.



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