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) for its first clinical trial involving human participants. This marks a significant milestone for Neuralink after facing previous challenges in obtaining approval.
Neuralink expressed in a tweet that the FDA's approval is a crucial initial step toward the future potential of their technology in assisting numerous individuals. However, the company did not provide specific details about the study's objectives and stated that recruitment has not yet begun, with further information forthcoming.
Elon Musk envisions that brain implants could potentially treat various conditions, such as obesity, autism, depression, and schizophrenia, while also facilitating activities like web browsing and telepathy. He gained attention last year when he expressed confidence in the safety of the devices to the extent that he would be willing to have them implanted in his own children.
Although Musk had previously made multiple predictions about Neuralink initiating human trials since 2019, the company only sought FDA approval in early 2022. According to seven current and former employees who spoke in March, the FDA raised several concerns that Neuralink needed to address before granting approval for human trials. These concerns included issues with the device's lithium battery, potential migration of implant wires within the brain, and the challenge of safely removing 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 flawed and rushed experiments. Additionally, the Department of Transportation is conducting a separate investigation into whether Neuralink unlawfully transported hazardous pathogens on chips removed from monkey brains without adequate containment measures. Furthermore, the U.S. Department of Agriculture's Office of Inspector General is investigating Neuralink for possible violations of animal welfare regulations, including the USDA's oversight of the company.