FDA denies Musk's humanoid dreams

According to Reuters, the FDA turned down Neuralink, Elon Musk's brain-computer interface company, for human trials in early 2022. The FDA cited dozens of problems with the company's device that employees are still trying to fix.

Despite the bold claims made by the company's CEO Elon Musk, FDA denied authorization for human trials using the same devices that caused harm to pigs.

Current and ex-employees of Neuralink 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," to Reuters in an interview.

The FDA's main safety concerns center around the device's battery system and its transdermal charging capabilities, which could fail and cause harm to surrounding tissue of the humans. The agency also worries about the risk of breaking the tiny, delicate electrical leads that extend into the patient's brain during device removal or regular use. These leads could migrate to other important brain parts and cause additional harm.

Despite Musk's confident claim during Neuralink's open house in November of securing FDA approval within six months, the reality seems far from this timeline. According to one employee, Musk doesn't fully grasp the seriousness of working with a person's brain, and the risks involved are not to be taken lightly.

Musk has been so confident about getting FDA approval since 2021. Back in the day, he tweeted:

Neuralink is working super hard to ensure implant safety & is in close communication with the FDA. If things go well, we might be able to do initial human trials later this year.

— Elon Musk (@elonmusk) February 1, 2021

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Receiving a rejection from the FDA for human-testing approval does not necessarily mean that a company will fail to ultimately gain approval. However, the fact that the FDA is pushing back on the approval process indicates that there are significant concerns about the device, according to over a dozen experts in FDA device-approval processes.

Previously, Neuralink has been accused by the animal rights group Physicians Committee for Responsible Medicine of botched surgeries that resulted in the deaths of monkeys. In a joint study with the University of California, Davis, Neuralink admitted that six monkeys had died due to complications arising from their experiments. Despite this, the company defended its research, stating it did not violate any laws.

On the Neuralink side, there is no official statement on the rejection from the FDA yet.

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