Elon Musk in a live broadcast with the surgical robot that would place the implants, in August 2020. Neuralink (AFP)
Neuralink, Elon Musk’s brain chip company, announced Thursday that it has received the green light from the pharmaceutical regulator to carry out its first human trial. The controversial businessman predicted in December that permission from the Food and Drug Administration (FDA), the office that oversees products, medicines and surgical procedures in the United States, would arrive during the first half of this year. He was not wrong, although the approval was not easy, since they heard a refusal last year. The company, founded in 2016, reported 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 public what Neuralink claimed on social media.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
— Neuralink (@neuralink) May 25, 2023
“Recruitment is not yet open for our clinical trial,” the company reported 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 chips made by the company could cure some types of paralysis and some cases of insomnia. The controversial mogul, who has always taken little care to mince words about him, even noted that the device could give users “superhuman” vision. At that time they showed one of the first implants of him, in a pig.
A year later, in 2021, Neuralink made one of its most viral presentations. A monkey, Pager, appeared in front of a television and closely followed what was happening on the screen, a Pong video game. The primate controlled the controls with his eyes alone thanks to a pair of semiconductors the size of a quarter that he had implanted in both hemispheres of his brain.
Musk said a few months ago that they had started “extremely careful” paperwork with the FDA and were working with the agency. “I think probably in six months we will be able to put our first Neuralink in a human,” said the controversial millionaire, who this week helped Florida Gov. Ron DeSantis launch his 2024 campaign on Twitter.
The implant in the hands of Musk, in a presentation in August 2020. Neuralink (AFP)
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 those in charge of the company began the legal process before the regulator. According to the Reuters agency, this first request was rejected by the FDA authorities shortly after it was submitted. The regulator doubted the safety of the battery that uses the semiconductor, made up of lithium. He worried that the tiny wires coming out of the brain could invade other areas of the skull. Finally, those in charge of the process also asked questions about the implications of removing the chip and whether this process could damage brain tissue.
A report from the British agency cited experts who doubted that Neuralink could quickly correct the points that worried the government body, which had the last word in 85% of human procedures performed in the last three years. “Neuralink doesn’t seem to have the experience and mindset to bring this to market soon,” a neural engineer was quoted as saying in the piece published in March.
Neuralink is not the only one preparing to carry out the first tests of its technology in 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 increase its workforce to become an emerging company with fifty researchers. His product, called Connexus Direct Data, promises paralyzed patients to regain some communication skills.
The promising profile of its technology led the FDA to include it in its select state-of-the-art device program, where 32 initiatives receive a faster review process, as they could benefit patients in their treatments and diagnoses. Another of the companies struggling in the nascent brain implant industry is Synchron. Companies have some differences in the size, weight, and performance of their semiconductors and in the surgical methods for attaching them. But everyone is optimistic about the future and the benefits it can bring to millions of people.
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