--- title: "Regulators Reportedly Rejected Elon Musk’s Application to Test Brain Chips in Humans" description: "US regulators denied Elon Musk's Neuralink's application to start testing the company's brain chips in humans last year, Reuters reports." date: "2023-03-02" modified: "2023-03-02" authors: - name: "Victor Tangermann" job_title: "Senior Editor" link: "https://futurism.com/authors/victor" url: "https://futurism.com/neoscope/regulators-rejected-elon-musk-application-brain-chips-humans" categories: - "Brain" - "Elon Musk" - "Future Society" - "Health & Medicine" - "Neuroscience and Brain" - "The Industrialists" tags: - "brain computer interface" - "elon musk" - "neuralink" --- # Regulators Reportedly Rejected Elon Musk’s Application to Test Brain Chips in Humans ![US regulators denied Elon Musk's Neuralink's application to start testing the company's brain chips in humans last year, Reuters reports.]() *\Image: Getty Images/Futurism\* Despite repeatedly promising that his brain-computer interface company Neuralink would start human clinical trials soon, Elon Musk failed to mention that US regulators denied the company's application to start testing the company's brain chips in humans last year. The news underscores [just how little weight]() Musk's infamously ambitious timeliness actually carry. According to [*Reuters*](), Neuralink only even submitted its application to the US Food and Drug Administration in early 2022. The application was reportedly denied, with staffers telling *Reuters* that regulators had identified dozens of issues that had to be addressed first, as well as safety concerns over the company's plans to implant lithium batteries in humans. Less than a year later, Musk [renewed his promise]() that human trials would be just months away. In short, the staffers are dubious that the company will be able to address these issues in time to meet Musk's overly ambitious deadlines. And that kind of challenge is really getting to the billionaire CEO. In late 2020, sources told *Reuters* that Musk shouted angrily about the company's slow progress on getting regulatory approval until about 2am. "He can’t appreciate that this is not a car," one source told the news agency. "This is a person’s brain. This is not a toy." Musk has been promising Neuralink's human trials would start imminently since at least 2019. In 2020, he promised the trials of the company's coin-sized brain chip, designed to eventually allow disabled patients to move and communicate again, would kick off in "[less than a year]()." In February 2021, he tweeted that the company was working with the FDA to push for "[human trials later this year]()." Roughly ten months later, his timeline slipped to "[next year]()." Finally, in December, [Musk promised]() human trials were just "six months away." Neuralink isn't technically obliged to publicize if or why its application was rejected by regulators. And besides, it's far from game over for the startup as it's not an uncommon occurrence. According to *Reuters*, only roughly two-thirds of all FDA applications for human trials get approved after the first application. Musk, however, has characteristically made some extremely bold promises about the future of the technology that didn't acknowledge those behind-the-scenes difficulties. The billionaire CEO is also known for butting heads with regulators, who he largely sees as an impediment. Like with his other ventures, including Tesla and SpaceX, Musk's approach has, broadly speaking, been "move fast and break things." In the medical field, however, that kind of mindset may not get you very far. "Everybody in the industry was saying: ‘Oh my God, they’re going to run straight into a brick wall,'" Kip Ludwig, former program director for neural engineering at the US National Institutes of Health (NIH), told *Reuters*. "Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon." Now, Neuralink is racing to get more data from animal trials to appease the FDA's concerns. But there may be even more regulatory stumbling blocks for the company to come. Last month, [*Reuters* reported]() that Neuralink may have illegally moved hazardous pathogens, thereby breaking federal law. Then there's Neuralink's competition, with rival brain-computer interface startup Synchron already [getting the go-ahead]() to start human trials last year. The company is also dealing with [major shakeups]() among its leadership. Musk himself is already spread very thin with his other ventures and pays very little attention overall to Neuralink, sources told *Reuters*. Neuralink clearly has its work cut out in getting approval from the FDA. After all, the risks involved are palpable — introducing a battery-powered device inside the brain and zapping certain areas is pretty invasive. **READ MORE:** [U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks]() \[*CNBC*\] **More on Neuralink:** *[Neuralink Under Investigation for Contaminated Brain Hardware]()* ## Author I've been at Futurism since 2017, where my role has evolved to encompass design, writing, and increasingly editing. I've always been fascinated by space exploration and advanced transportation, which I've leaned into by interviewing luminaries in those fields while closely following the dimensions of policy and regulation that allow next-generation projects to succeed -- or, sometimes, to fail. I'm also keenly interested in the effects of generative AI on society, policies, and democratic institutions, as well as clean energy, physics and biology, and the vagaries of tech leadership. My work for Futurism has been cited by publications including Ars Technica, Gizmodo, PC Magazine, Jalopnik, Fox News, and the New York Post. I spent my childhood living in locations including Manila, the Philippines, and Geneva, Switzerland, attended McGill University, and now live in Toronto, Canada. Before Futurism I worked at AskMen and a small photography studio. In my free time, I'm an avid gardener, foodie, and craft beer lover, as well as a maker of artisanal hot pepper sauces. I have a magnificent dog named Freida. ### Author social links [Bluesky]()