Orchestra man, renaissance-style character, entrepreneur without borders, entrepreneur admired and hated at the same time, Elon Musk plays all the keys.
Whether it manufactures electric cars (Tesla), launches rockets into space (Space X), causes chaos in the digital public square (Twitter) or enters the race 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, the project in which technology is most closely linked to the concept of human existence.
The federal administration that regulates food and drugs in the United States (FDA) has given the go-ahead for Neuralink, its firm to implant chips in people's brains, to start the first clinical trial with humans of the experimental device.
The company announced it, although the FDA has not said either donkey or beast, nor does any kind of confirmation appear on its website.
The approval is a milestone for the company, which has been developing a coin-sized computer device to be surgically inserted by a robot that should be able to decode brain activity and link the on computers. The robot, called R1, has the ability to open the skull to implant the computer.
"We are excited to share that the FDA has cleared our first human clinical study," Neuralink announced on Twitter Thursday night.
He 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 has not yet opened and that it will soon offer more details.
The aim of the implant is to enable a person with a debilitating disease, such as amyotrophic lateral sclerosis (ALS), or who has the aftermath of a stroke, to communicate through their thoughts.
At the presentation of the project, the company showed a video in which a monkey telepathically types on a screen to get 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 vision for 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 when he expressed complete confidence in the device's safety, to the point that he would be willing to implant it in his children.
Since 2019, he had predicted at least four times that Neuralink would begin 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 expressed several concerns that the firm had to resolve before receiving the green light. The main problems were related to the lithium battery of the devices, the possibility of the implant cables migrating into the brain and the need to remove the device with guarantees of not damaging the brain tissue.
Neuralink was founded in 2016, operates in Fremont (California) and is expanding to 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 obtained large resources and attracted the attention of investors.
Other companies such as Blackrock Neurotech and Synchron have implanted devices in people during clinical trials, and at least 42 individuals are wearing brain computer implants. They have achieved achievements that seemed to belong in the territory of science fiction, like a quadriplegic walking, little by little, but with a natural step.
But while those companies want to commercialize brain transplants focused on medical needs, Neuralink has much bigger ambitions. Their devices aim not only to restore human functions, but to improve them. "We want to surpass human performance without disabilities with our technology," this firm tweeted in March.
Neuralink has been the subject of several federal investigations. Lawmakers this month urged regulators to investigate whether the makeup of a team overseeing Neuralink's animal testing contributed to botched and rushed experiments. And the Department of Agriculture is investigating whether the use of these animals amounted to an act of torture.
