Neuralink, Elon Musk’s brain chip company, announced Thursday that it has received the go-ahead from the drug regulator for its first human trial. The controversial businessman predicted in December that authorization from the Food and Drug Administration (FDA), the office that oversees products, drugs and surgeries in the United States, would arrive during the first half of this year. He was not mistaken, although the approval was not easy, because they heard about the refusal last year. The company, which was founded in 2016, said 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 announced what Neuralink claimed on social media.
We are excited to share that we have received FDA approval to launch our first human clinical study!
This is the result of the incredible work that the Neuralink team has done in close collaboration with the US Food and Drug Administration and represents an important first step that will one day allow us…
—Neuralink (neuralink) May 25, 2023
“Not yet open for recruitment in our clinical trial,” the company wrote on Twitter, promising more information in the coming days. Neuralink has been raising expectations about its progress for several years now. In 2020, Musk claimed in a presentation that chips made by the company could treat some types of paralysis and some cases of insomnia. The controversial billionaire, always short of his words, even suggested that the device could give users “superhuman” vision. At the time they were showing one of the first transplants in a pig.
A year later, in 2021, Neuralink has one of its most viral offerings. A monkey, Pager, appeared in front of a TV and closely watched what was happening on the screen, a video game pong. The primate controlled the controls with just his eyes, thanks to a pair of semiconductors the size of a 25-cent coin implanted in both hemispheres of his brain.
Musk said a few months ago that they had begun “very careful” paperwork with the FDA and have been working with the agency. “I think it’s probably within six months that we will be able to put the first Neuralink in a human,” the controversial millionaire, who helped Florida Governor Ron DeSantis this week launch his 2024 campaign, said on Twitter.
Prior to that occasion, Musk had bragged at least three times since 2019 that he was seeking approval from the Food and Drug Administration for human clinical trials. But those responsible for the company did not begin legal action before the regulator until 2022. According to Reuters, the Food and Drug Administration denied that first request shortly after it was submitted. The regulator questioned the safety of the battery, which used a lithium semiconductor. There has been concern that the tiny wires emerging from the brain could be invasive in other areas of the skull. Finally, those responsible for the operation also asked questions about the implications of removing the chip and whether the process could damage brain tissue.
A report by the British agency cited experts who doubted Neuralink could quickly correct points that worried the government body, which has had the final say on 85% of human procedures performed in the past three years. “Neuralink doesn’t seem to have the experience and mindset to bring this to market so soon,” a neuroengineer was quoted as saying in a March article.
Neuralink isn’t the only one preparing to conduct the first human tests of its technology. One of its main competitors, Paradromics, is also looking to get the green light. Founded in 2015, the Austin-based company has made leaps and bounds with its transplants and managed to grow its workforce into a startup of fifty researchers. His product, called Connexus Direct Data, promises paralyzed patients to regain some communication skills.
The promise of its technology has led the FDA to include it in the Advanced Devices Program, where 32 initiatives receive a faster review process, where they can benefit patients with their treatments and diagnoses. Another company struggling in the fledgling brain implant industry is Synchron. Companies have some differences in the size, weight, and performance of their semiconductors, and in the surgical methods to connect them. But everyone is optimistic about the future and the benefits it can bring to millions of people.
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