Neuralink, the brain-implant company founded by Elon Musk, announced on Thursday that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its first-in-human clinical trial. This marks a significant milestone for Neuralink, following earlier challenges in obtaining regulatory clearance.
In a tweet, Neuralink stated that the FDA’s approval “represents an important first step that will one day allow our technology to help many people.” The company did not provide specific details about the study’s objectives, noting that it is not currently recruiting participants but will release more information in the near future.
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Requests for comments from Neuralink and the FDA regarding the approval were not immediately answered by Reuters.
Elon Musk envisions that brain implants developed by Neuralink could potentially address a wide range of conditions, including obesity, autism, depression, and schizophrenia, and even enable functions such as web browsing and telepathy. Last year, he garnered attention by expressing his confidence in the safety of the devices, stating that he would be willing to have them implanted in his own children.
Since 2019, Musk has made predictions on at least four occasions about Neuralink beginning human trials. However, the company only recently sought FDA approval in early 2022, and according to seven current and former employees who spoke to Reuters in March, the application was initially rejected by the agency.
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Neuralink faced several concerns from the FDA that needed to be addressed before human trials could be sanctioned, as noted by the employees. These concerns included issues related to the lithium battery used in the device, the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue.
Founded in 2016, Neuralink has been the subject of various federal investigations. In May, U.S. lawmakers called for regulators to examine whether the composition of a panel overseeing animal testing at Neuralink contributed to mishandled and rushed experiments.
Separately, the Department of Transportation is investigating allegations that Neuralink unlawfully transported hazardous pathogens on chips removed from monkey brains without appropriate containment measures.
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Furthermore, the U.S. Department of Agriculture’s Office of Inspector General is conducting an investigation into potential animal-welfare violations at Neuralink. This probe is also evaluating the USDA’s oversight of the company.
Neuralink has not responded to requests for comments regarding these ongoing investigations.
While Neuralink’s FDA approval for the first-in-human clinical trial represents a significant step forward, it remains to be seen how the company will address the concerns raised by regulators and navigate the complex landscape of brain implant technology. The outcome of the upcoming study will undoubtedly shed light on the potential applications and limitations of this groundbreaking technology in the future.
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