One-man band, a Renaissance-style character, an entrepreneur without borders, an admired and hated businessman at the same time, Elon Musk plays all the sticks.
Maybe it makes electric cars (Tesla), launches rockets into space (Space X), causes chaos in the digital public square (Twitter) or enters the career of the artificial intelligence business (X.AI Corp).
Now, in addition, it receives historical support for the development of one of its most sophisticated and risky challenges, one in which technology is more linked to the concept of human existence.
The federal administration that regulates food and drugs in the United States (FDA) gave the go-ahead for Neuralink, its company that implants chips into people's brains, to start the first clinical trial of this experimental device in humans.
This was announced by this company yesterday, although the FDA did not make any comments nor was there any confirmation on its website.
This approval marks a milestone for the company, which has been developing a coin-sized computing mechanism to be surgically inserted by a robot and capable of decoding brain activity and linking it to computers. The robot, which he has named R1, has the ability to slice through the skull to implant that computer.
“We are excited to share that the FDA has cleared the launch of our first human clinical study,” Neuralink tweeted Thursday night.
He also added that “this is an important first step towards what will one day allow our technology to help many people.” Musk retweeted the message to congratulate his team. The company clarified that the recruitment period is not yet open and that it will soon offer more details.
The aim of the implant is to allow a person with a debilitating disease, such as amyotrophic lateral sclerosis (ALS), or who suffers from a stroke, to communicate through their thoughts.
In the presentation of the project, the company exhibited a video in which a monkey telepathically types on a screen to win a prize in the form of food. What the little computer does is translate the neural spikes generated by the brain into data that can be interpreted by the computer on which it is typed.
Musk's view of these brain grafts is that they could cure a variety of conditions, including obesity, autism, schizophrenia, as well as enable web browsing and telepathy. A few months ago, Musk made headlines by expressing his complete confidence in the safety of the devices to the point that he would be willing to implant them in his own children.
Since 2019, at least four times he predicted that Neuralink would start human trials. But the company only sought FDA approval once, in late 2022, and the agency then rejected the application.
According to Reuters, the Administration highlighted several concerns that the firm needed to resolve before giving the green light. The main problems were related to the lithium battery in the devices, the possibility of the implant wires migrating into the brain, and the challenge of removing the device with guarantees of not damaging brain tissue.
Neuralink was founded in 2016, maintains its operations in Fremont (California) and has to expand into a campus still under construction in Austin (Texas). It has more than 400 employees and has raised more than $363 million. Thanks to Musk's support, the company has raised huge resources and captured the attention of investors.
Other companies such as Blackrock Neurotech and Synchron have grafted their gadgets onto people during clinical trials, and at least 42 people have implanted brain computers. They have accomplished things that seemed like they belonged in the territory of science fiction, like a quadriplegic walking slowly but with a natural gait.
But while those companies seek to commercialize those brain grafts focused on medical needs, Neuralink has much bigger ambitions. His devices seek not only to restore human functions, but to improve them. "We want to exceed human performance without disabilities with our technology," this firm tweeted in March.
Neuralink has been the subject of several federal investigations. Lawmakers this May urged regulators to investigate whether the composition of a team that oversees animal testing at Neuralink contributed to botched and rushed experiments. And the Department of Agriculture is investigating whether the use of these animals was an act of torture.