Musk’s Neuralink claims it has FDA approval for human trials

26 May 2023

Elon Musk in 2020. Image: Steve Jurveston/Flickr (CC BY 2.0)

While the FDA is yet to make an official announcement, Neuralink said the approval is ‘an important first step’ for its implantable brain chip.

Neuralink, the brain-implant technology company founded by Elon Musk, claims it has received approval from the US Food and Drug Administration (FDA) to run clinical trials on humans.

In a tweet yesterday (25 May), Neuralink said that the FDA approval “represents an important first step that will one day allow our technology to help many people”.

The company is yet to begin recruitment for its first in-human trials.

Founded in 2016 by Musk along with experts in neuroscience and robotics, San Francisco-headquartered Neuralink has been working on brain-computer interface technology that includes an implantable chip that can allow humans to control computers with their brain.

In the long term, Musk hopes the Neuralink devices will enable people to achieve “superhuman cognition”. The company’s first product, the N1 Link device, is an implant that transmits data via a wireless connection.

While it may sound like science fiction, the company has been trialling the technology with pigs and monkeys. One monkey even made headlines when it was shown playing the classic video game Pong with its mind via two N1 Link chips embedded in its brain.

But the company, like most others associated with Musk, has been mired in controversy.

Neuralink was under federal investigation in the US for potential animal welfare violations during its trials.

A Reuters report in December based on records and sources with direct knowledge of the company’s animal testing operations found that Neuralink had killed about 1,500 animals, including more than 280 sheep, pigs and monkeys.

While animal deaths are not uncommon during such trials, the investigation followed internal staff complaints around how the company was allegedly rushing its animal testing, resulting in botched experiments. Neuralink denied these claims earlier this year.

Moreover, while the company has confirmed the news, further endorsed by Musk in a retweet congratulating the team, the FDA is yet to officially make an announcement.

In 2018, Musk tweeted that he had secured funding to take Tesla private at $420 a share, but the US Securities and Exchange Commission found his series of tweets to be “false and misleading”. This led to a settlement, fines and Musk stepping down as chair of the company.

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Elon Musk in 2020. Image: Steve Jurveston/Flickr (CC BY 2.0)

Vish Gain is a journalist with Silicon Republic