Neuralink, the brain-implant company founded by Elon Musk, has announced that it has received FDA approval for the first human trials of its experimental device. This regulatory approval is a significant milestone for Neuralink, which has been developing a brain-implant device capable of decoding brain activity and linking it to computers. So far, the company has conducted research only on animals.

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Neuralink shared the news of the FDA approval on Twitter, describing it as an important first step towards helping many people with their technology. Elon Musk, the CEO of Neuralink, retweeted the announcement, congratulating his team on the achievement.

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While Neuralink did not immediately provide further details or comments, the FDA released a statement acknowledging that Neuralink had received approval for its investigational device exemption, allowing the company to conduct human clinical trials for its device.

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It's worth noting that Elon Musk has previously made premature claims of regulatory approval, such as his announcement in 2017 about receiving "verbal govt approval" for an underground Hyperloop project. However, officials did not directly confirm his claim, indicating that there were no formal measures in place for such a project.

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Neuralink, founded in 2016, is a privately held firm with operations in Fremont, California, and a campus under construction in Austin. With backing from Musk, the company has brought significant resources and investor attention to the field of brain-computer interfaces, where researchers are developing electronic implants to decode brain activity and communicate with computers. This technology has the potential to restore function to people with paralysis and conditions like amyotrophic lateral sclerosis (ALS).

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While other companies in the field are primarily focused on medical applications, Neuralink has broader ambitions of creating a device that not only restores human function but also enhances it. They aim to surpass able-bodied human performance with their technology, as stated in one of their tweets.

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Neuralink's brain chip technology involves an electrode-laden computer chip that is surgically implanted into the brain's surface using a robotic device. The company takes a more invasive and high-bandwidth approach compared to some competitors, aiming to transfer brain-to-computer data more rapidly. Musk envisions regular upgrades for the devices.

It remains unclear when exactly the clinical trials in humans will begin. Neuralink's patient registry indicates that only patients with specific conditions, such as paralysis, blindness, deafness, or the inability to speak, are eligible to participate.

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While a clinical trial is a significant step, it does not guarantee regulatory or commercial success. Companies like Neuralink will face intense scrutiny from the FDA to ensure the safety and reliability of their devices. Additionally, ethical and security concerns arise from a technology that could potentially confer a cognitive advantage to individuals with an implant.

Elon Musk's Neuralink venture is one of his most ambitious endeavors among his various business interests, which range from electric cars and rockets to artificial intelligence and social media.

May 23 2023.