Elon Musk can finally begin testing his brain chip on humans. His company Neuralink, which focuses on brain-implant technology, announced that it has received approval from the US Food and Drug Administration (FDA) for its first human clinical trial. This marks a significant milestone for Neuralink, as it had faced challenges in obtaining approval in the past.
Neuralink expressed its excitement about the FDA’s approval in a tweet, stating that it is an important first step towards helping many people. However, the company did not provide specific details about the study, stating that recruitment has not yet begun and more information will be available soon. Neither Neuralink nor the FDA responded immediately to requests for comment from Reuters.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!,” Neuralink said in a tweet.
Elon Musk had previously said that brain implants could potentially address various conditions such as obesity, autism, depression, schizophrenia, and even enable functions like web browsing and telepathy. Musk gained attention last year when he expressed confidence in the safety of the devices, even stating that he would be willing to implant them in his own children.
Although Musk had previously made predictions about Neuralink conducting human trials on multiple occasions since 2019, the company only sought FDA approval in early 2022. In March, seven current and former employees disclosed that the FDA had raised concerns that needed to be addressed before approving human trials. These concerns included the lithium battery of the device, the possibility of the implant’s wires moving within the brain, and the safe extraction of the device without causing damage to brain tissue.
Since its founding in 2016, Neuralink has been the subject of several federal investigations. In May, US lawmakers urged regulators to examine whether the composition of a panel overseeing animal testing at Neuralink contributed to problematic and rushed experiments. Additionally, the Department of Transportation is investigating whether Neuralink unlawfully transported hazardous pathogens on chips taken from monkey brains without proper containment measures. The US Department of Agriculture’s Office of Inspector General is also conducting an investigation into potential animal-welfare violations at Neuralink and the USDA’s oversight of the company.