US regulators have not allowed Neuralink, Elon Musk’s company, to test its brain implants on humans. Meanwhile, the company has conducted tests on animals and has a long-term goal of enabling paralyzed people to walk or restoring sight to the blind. In question: problems with the lithium battery, the way in which the chip can be removed or the stability of the son of the implant. The cyborg still seems to be far from us.
In 2016, Elon Musk founded Neuralink: a start-up specialized in the human-machine interface. Last November, he claimed that he only needed a few more months before he could put a Neuralink implant in a human. A statement that the founder of it has made regularly for several years. As usual, Elon Musk was confident, saying that he had submitted most of the documents requested by regulators and that he was in constant discussion with them. He went without counting on the Food and Drug Administration (FDA), which did not accept Neuralink’s request for authorization to test its chips in humans.
Neuralink Rejected by FDA: No Human Testing
is the news agency Reuters which reveals the information based on seven employees, some still on site, others no longer with the company. Neuralink would have applied for authorization in early 2022, long after Elon Musk’s first bombastic promises. A rejected request, but of which we have not heard.
According to the employees, the agency noted dozens of issues the company must address before human testing (some being ” relatively minor ”), although it is a critical step in the implant design process. Without human testing, commercialization would not be possible. They add that ” The agency’s main safety concerns centered on the device’s lithium battery, the potential for the implant’s tiny wires to migrate to other areas of the brain, and whether and how the device can be removed without damaging brain tissue. . ».
For some brain implant experts, if the battery were to fail, it could damage brain tissue. Some employees say the FDA felt Neuralink needed to further demonstrate the reliability of the lithium batteries used. A demonstration that is all the more complicated as Neuralink seeks to be able to recharge them remotely. As for the children, they could induce inflammation, impair function in critical areas of the brain, and rupture blood vessels “and I could” erode the efficiency of the device according to Victor Krauthamer, a former FDA official for thirty years. This is because the brain is a very delicate organ and, above all, very soft. For the Food and Drug Administration, the chip must be removable without damaging brain tissue and must not cause overheating. While Neuralink has acknowledged some weaknesses in the past, the company has downplayed them. As indicated Reuters In their article, neuroscience and industry experts disagree with Neuralink’s responses to the FDA’s requirements.
The Neuralink implant would still be far from being tested in humans
Neuralink would work internally to resolve all of these issues in order to test your implant as quickly as possible. However, for three employees, the company would be far from quickly resolving all these concerns. The information is also scarce: Neuralink has not formalized its trial request, nor the reasons for its rejection by the FDA. You are also not required to disclose your information to your investors, who may be a source of media leaks. In an internal document, Reuters said learn that ” Neuralink hoped the FDA would approve human trials for its brain implant by March 7, 2023. »
This does not mean that Neuralink will never be able to test your implants. If it fixes the issues highlighted by the FDA, it could earn future approval. On the other hand, according to a dozen experts interviewed by Reuters« The agency’s refusal is a sign of serious concerns. “. Remember that ” this rejection also increases the stake and difficulty of subsequent authorization requests from the company. “This is even more the case from the FDA” claims to have passed around two-thirds of all human test applications for devices on the first try in the last three years Internally, some employees would have a negative view of the FDA: the institution represents a generally slow government that stifles innovation.
If Neuralink does not get the permit after three attempts, the company can give up to focus on other projects. Even if you do get an approval, getting the marketing one is even more difficult.
It’s still a medical chip, and the FDA can’t afford to let any company test neurological devices without certain guarantees. What’s more, she herself suffered controversy after the approvals ”, such as the authorization in 2021 of a treatment for Alzheimer’s disease without conclusive evidence of its efficacy. However, the FDA, particularly under pressure from Congress (through the enactment of federal laws), has expedited review procedures for testing human brain devices. Now, you have just thirty days to respond to requests for human trials.
Why Neuralink Can’t Move Forward: Because It’s Moving Too Fast
The controversies about Neuralink are multiple and increasingly seem to derive from a systemic problem, more structural than financial or human. For some of your employees, Neuralink’s regulatory challenges stem largely from its culture “. Elon Musk obeys, Neuralink is taking great steps with ambitious goals in a very short time. An operation that seems similar to the one that Elon Musk applies with his other companies: Tesla, SpaceX (specifically with Starlink) and more recently Twitter. Yes this culture is heavily criticized by employees, it would appear that there remains a core comprised of employees loyal to the company, as well as certain industrial investors.The stakes are high: while Neuralink is arguably the highest profile brain device development company , is not the only one.The competition has been around for years and continues its work.
The problem is that this can lead to design errors, specific difficulties. In the case of Neuralink, the company is being asked to undergo human testing. But for this, every detail of the implant must respect the safety protocols. The test request comes even as a federal investigation was opened last December into Neuralink for “ possible violation of animal welfare legislation “. Due to tight deadlines and mounting pressures, Neuralink would not have dealt with the animals used for its tests: what’s worse, many animal deaths were due to human error. Last month, the Department of Transportation of the US opened an investigation for illegal transport of dangerous pathogens. Neuralink would have transported microchips taken from the brains of monkeys”, without adequate containment measures. »
Elon Musk: a CEO who would be toxic for Neuralink
Research Reuters it goes beyond simply refusing FDA clearance. As in previous revelations, a toxic element for Neuralink appears: Elon Musk. More than a dozen employees told the news agency: a work environment that, while demanding and ambitious, is also lazy and disorganized. Of eight founders, almost all have jumped ship: almost only Elon Musk remains, who would pay less attention to Neuralink than to his other companies. Tesla, SpaceX and even Twitter are producing more images and immediate results. Besides, ” Musk’s emails to Neuralink employees often come from his SpaceX address. According to two people.
One of the strategies in line with Elon Musk’s vision of a company is to hire and promote young employees. Fresh graduates or still interns, they would be legion in Neuralink, some teams were composed only of members under thirty. A strategy that, beyond its ideological aspect about the fact that young people would innovate better than older ones, saves money.
Elon Musk’s dream: the augmented human being
Reuters remember that Neuralink “ it would allow the paralyzed to walk, the blind to see, and eventually turn people into cyborgs.Evils that today are intractable, except thanks to certain gadgets that are still experimental.
Elon Musk has repeatedly laid out his vision for Neuralink. how do you remember Reuters he would like it both disabled and healthy people will go to neighborhood facilities to have devices quickly inserted whose functions range from curing obesity, autism, depression or schizophrenia to Internet browsing and telepathy. Neuralink chips could eventually make humans qualify as cyborgs.
The CEO of the company would also like the implants to be discreet, so that it is not known who is wearing them and who is not. In 2020, he even went further: “ You will be able to record and play memories… The future is going to be strange. “A statement reminiscent of episode 3 of the first season of black mirror(2011),return to image. In it, most humans have a chip behind their ears that allows them to store their memories and relay them.
However, some Neuralink executives are more humble about the implant. Last month, vice president of engineering Dogjin Seo explained that the short-term goal was not to restore mobility to paralyzed patients, but to help them communicate via computer text, to avoid typing on an eye-tracking keyboard.
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