Elon Musk‘s brain-implant company Neuralink on Thursday said the US Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval. FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon. Neuralink and the FDA did not respond to requests for comment.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. He made headlines last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his kids.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the firm only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees said. FDA had pointed out many concerns to Neuralink that needed to be addressed before sanctioning human trials,according to the employees. Issues involved the possibility of the implant’s wires migrating within the brain.
Neuralink has been the subject of several federal probes. In May, US lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. He made headlines last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his kids.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the firm only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees said. FDA had pointed out many concerns to Neuralink that needed to be addressed before sanctioning human trials,according to the employees. Issues involved the possibility of the implant’s wires migrating within the brain.
Neuralink has been the subject of several federal probes. In May, US lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.