Neuralink, Elon Musk’s company specializing in brain implants, announced on Thursday that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct its first clinical trial involving human subjects. This significant development comes after previous challenges in obtaining approval.
Neuralink expressed the importance of the FDA’s endorsement, stating in a tweet that it marks a crucial initial step towards leveraging their technology to benefit numerous individuals. While the company did not provide specific details about the study or initiate recruitment at this stage, it assured that more information would be shared soon.
As of now, there have been no comments from Neuralink or the FDA in response to Reuters’ inquiries.
Elon Musk envisions brain implants as potential remedies for various conditions, including obesity, autism, depression, schizophrenia, and even as tools for web browsing and telepathy. In a noteworthy statement last year, Musk displayed his confidence in the safety of the devices by expressing his willingness to have them implanted in his own children.
Neuralink had previously made multiple predictions since 2019 regarding the commencement of human trials. However, the company did not seek FDA approval until early 2022, and the application was initially rejected, according to seven current and former employees who spoke with Reuters in March.
Concerns raised by the FDA that needed to be addressed before authorizing human trials included issues related to the lithium battery of the implant, the potential migration of the device’s wires within the brain, and the safe extraction of the implant without causing harm to the brain tissue, as disclosed by the employees.
Founded in 2016, Neuralink has been subject to several federal investigations.
In May, U.S. lawmakers called for regulators to investigate whether the composition of a panel overseeing animal testing at Neuralink contributed to poorly executed and hasty experiments.
Additionally, the Department of Transportation is conducting a separate probe to determine whether Neuralink violated regulations by transporting hazardous pathogens on chips extracted from monkey brains without adequate containment measures.
The U.S. Department of Agriculture’s Office of Inspector General is also investigating Neuralink for potential animal-welfare violations. This inquiry has included an examination of the USDA’s oversight of Neuralink.
Neuralink has yet to provide any comments regarding these investigations upon receiving requests for clarification.