Musk has said his brain implant company, Neuralink, will make the paralyzed walk, the blind see and eventually turn people into cyborgs. But the firm still struggles to secure clinical-trial approval for the relatively modest goal of helping disabled people type.
Tesla Motors CEO Elon Musk unveils a new all-wheel-drive version of the Model S car in Hawthorne, California October 9, 2014.On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness.
Neuralink has not disclosed details of its trial application, the FDA's rejection or the extent of the agency's concerns. As a private company, it is not required to disclose such regulatory interactions to investors.
“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon.”former program director for neural engineering at the U.S. National Institutes of Health Still, Musk retains the full confidence of many loyal Neuralink staffers and some industry investors, who point to his past successes in taking on extreme challenges as the founder of Tesla and rocket-builder SpaceX.
Such high-flying ambition has contributed to Neuralink's estimated worth of more than $1 billion, far higher than its competitors, according to four people familiar with the private valuation. "Everybody in the industry was saying: 'Oh my God, they're going to run straight into a brick wall,'" Ludwig said of Musk's bid for FDA approval. "Neuralink doesn't appear to have the mindset and experience that's needed to get this to market anytime soon."
The Department of Transportation said its investigation is ongoing. The U.S. Department of Agriculture's Office of Inspector General, which is conducting the animal-treatment probe, declined to comment.While Neuralink garners outsized attention because of its famous founder, more than a dozen companies are developing or manufacturing devices in the wider $6 billion field of so-called neuromodulation devices, which record or stimulate neural activity.
Neuralink's electrodes are attached to wires thinner than a human hair, which are implanted in the brain, the company has said. It also aims to revolutionize surgeries with a robot to sew its microscopic wires into brain tissue, while avoiding blood vessels, in minutes. The episode reflects a wider view at Neuralink that the government generally moves slowly and stifles innovation, five current and former employees said. In a presentation to staff last fall, the company set a goal of making the FDA "our #1 Fans by showing that we go above and beyond," according to a document reviewed by Reuters.
. Musk himself often pays more attention to his higher profile ventures – Tesla, SpaceX and Twitter – than to Neuralink, three company sources said. Musk's emails to Neuralink staffers often come from his SpaceX address, said two people who reviewed them. A different Neuralink source recalled a meeting in late 2020 or early 2021 in which an angry Musk shouted until about 2 a.m. about what he called the company's slow regulatory progress. When executives called his expected timeline unrealistic, Musk replied that he would make the FDA understand the need for fast approvals. Musk has participated in some phone calls between Neuralink and the agency, often seeking to expedite human trials, according to two people with knowledge of the calls.
Since Musk ousted Hodak, a coalition of executives has filled the gap, though employees often disagree on who is truly in charge. "The threads can cause damage because brains are very, very soft and very delicate," Krauthamer said.
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