Elon Musk's brain-implant company Neuralink on Thursday said the U.S. 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.
The 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.Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employeesThe FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees.
whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.by the U.S. Department of Agriculture's Office of Inspector General for potential animal-welfare violations. This probe has also been looking at the USDA's oversight of Neuralink.
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