Neuralink, Elon Musk’s brain-implant company, has obtained clearance from the U.S. Food and Drug Administration (FDA) for its first human clinical trial. This milestone comes as the company faces investigations related to its handling of animal experiments.
Neuralink stated that the FDA approval is a significant first step toward helping many people, although specific details about the trial were not disclosed. The FDA confirmed the clearance for Neuralink’s brain implant and surgical robot but did not provide further information.
Neuralink has been under federal scrutiny following reports of rushed and flawed surgeries on animals. Lawmakers have called for investigations into potential conflicts of interest in the panel overseeing animal testing, and the Department of Transportation is examining allegations of illegal transportation of pathogens.
The U.S. The Department of Agriculture’s Office of Inspector General is also investigating possible animal-welfare violations.
Despite earlier predictions, Neuralink’s application for human trials was rejected by the FDA due to safety concerns. The issues raised by the FDA included the device’s lithium battery, wire migration within the brain, and the safe removal of the implant without damaging brain tissue.
