Elon Musk’s brain chip company Neuralink announced on Thursday that it has received the go-ahead from pharmaceutical regulators to conduct its first human trials. The controversial businessman predicted in December that approval from the Food and Drug Administration (FDA), the office that oversees products, drugs and surgical procedures in the United States, would come during the first half of this year. He was not wrong, although approval was not easy, as he had heard the denial the previous year. The company, founded in 2016, explained this afternoon that this is the first step that will allow its technology to “help a lot of people.” So far, the regulator has not made Neuralink’s claim public on social media.
We are excited to share that we have received FDA approval to begin our first human clinical study!
This is the result of the incredible work done by the Neuralink team in close collaboration with the FDA and represents an important first step that may one day…
— Neuralink (@neuralink) May 25, 2023
“Recruitment for our clinical trial is not yet open,” the company explained on Twitter, promising more information in the coming days. Neuralink has been raising expectations about its advances for several years. In 2020, Musk claimed in a presentation that the chips made by the company could cure some types of paralysis and some cases of insomnia. The controversial tycoon, who is always short on his words, even said that the device could give users “supernatural” vision. At that time he was showing his first transplant in a pig.
A year later, in 2021, Neuralink presented one of its most viral presentations. Pager, a monkey, appeared in front of a television and closely followed the Pong video game that was happening on the screen. The primate controlled movement with its eyes alone, thanks to a pair of 25-cent coin-sized semiconductors implanted in both hemispheres of its brain.
Musk said a few months ago that he had initiated “extremely careful” paperwork with the FDA and was working with the agency. “I think maybe in six months we’ll be able to put our first Neuralink in a human,” said the controversial millionaire, who this week helped Florida Gov. Ron DeSantis launched his 2024 campaign on Twitter.
Prior to that occasion, Musk had boasted at least three times since 2019 that he was seeking FDA approval for human clinical trials. But it was not until 2022 that the company in charge initiated the legal process before the regulator. According to the Reuters agency, this first request was denied by FDA officials shortly after it was submitted. The regulator cast doubt on the safety of batteries using semiconductors made from lithium. There was concern that the tiny wires coming out of the brain could be invasive to other areas of the skull. Finally, the people in charge of the procedure also asked questions about the effects of removing the chip and whether the procedure could damage brain tissue.
A report by the British agency cited experts who doubted Neuralink could quickly fix issues that worried the government body, which had the final word on 85% of human procedures performed in the past three years. The article published in March quoted a neural engineer as saying, “Neuralink doesn’t seem to have the experience and mindset to get this to market quickly.”
Neuralink is not the only company preparing to conduct the first tests of its technology on humans. One of its main rivals, Paradromics, is also looking to get the green light. Founded in 2015, the Austin-based company has made leaps and bounds with its implants and has managed to grow its workforce to become a growing company with fifty researchers. Their product, called Connexus Direct Data, holds promise for helping paralyzed patients regain some communication skills.
The promising profile of its technology prompted the FDA to include it in its Selective Cutting Edge Devices program, where 32 initiatives receive an expedited review process because they can benefit patients in their treatment and diagnosis. One of the companies struggling in the neonatal brain implant industry is Syncron. The companies have some differences in the size, weight, and performance of their semiconductors, and in the surgical methods used to connect them. But everyone is optimistic about the future and that millions of people can benefit from it.
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