Elon Musk's ambitious plans to help paralyzed individuals walk and restore sight to blind people through his brain-computer interface company, Neuralink, is facing major regulatory hurdles that could halt the company's ambitious timeline to kick off human trials in May 2023.
An image of a brain chip designed to interface with the brain and has several small electrodes extending from it.
The Regulatory Hurdles Facing Neuralink's Brain Chip
Elon Musk's neurotechnology company that is developing a device called the "Link" that allows humans to interact with computers and other machines through their thoughts is up against significant roadblocks as it attempts to secure approval from the U.S. Food and Drug Administration (FDA) to begin human trials of its coin-sized device, according to IEEE Spectrum.
Despite Neuralink's ultimate goal to improve the way humans interface with technology and help treat neurological disorders and injuries, the company is still struggling to demonstrate the safety and efficacy of its coin-sized brain chip.
The FDA turned down Neuralink's 2022 application as it was found to have several deficiencies, including issues with the battery and charging mechanism of the device, the possibility of implanted electrodes moving around and causing harm to the brain tissue, and the potential for the brain to get damaged during the device's removal or upgrade.
Neuralink's efforts to kick off human trials for its brain chip this May will face additional hurdles due to investigations by other government regulators.
The U.S. Department of Agriculture is investigating the company's alleged animal abuse, while the Department of Transportation is investigating the company's alleged mishandling and interstate transport of biohazardous materials, such as neural implants collected from diseased animal subjects.
These investigations are not expected to affect the FDA's data evaluation in Neuralink's next application. Still, they may complicate the process because the FDA may require new data if the experiments are tainted. Animal studies may have to be redone in case they are unreliable, according to Victor Krauthamer, a visiting professor of biomedical engineering at George Washington University and former acting director of the FDA's Division of Neurological and Physical Medicine Devices.
From Paralysis to Sight: Evaluating the Efficacy of Neuralink's Coin-Sized Device
Even though the company's lofty goals have been well publicized, such as enabling the paralyzed to walk and blind people to see again, it is unclear how the FDA will view these claims when evaluating the device's efficacy.
Krauthamer told IEEE Spectrum, "It may raise more questions for them because of these very broad, unsubstantiated claims...the FDA just reviews the evidence in front of them, but there's a context to that, and I think that context may bring out additional caution."
The company is racing against a competitor called Synchron, which has already beaten Neuralink to human trials in 2021 and is now starting patient enrollment, further adding to the pressure.
The company's regulatory hurdles could delay Neuralink's planned human trials, jeopardizing the company's future ambitions. However, given Musk's enthusiasm for the project, it is unlikely to be the last we hear about Neuralink's progress.
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