Elon Musk’s Neuralink received US Food and Drug Administration clearance for its first-in-human clinical trial, a critical milestone as it faces US probes over its handling of animal experiments.
Elon Musk’s Neuralink received US Food and Drug Administration clearance for its first-in-human clinical trial, a critical milestone for the brain-implant startup as it faces US probes over its handling of animal experiments.
In one instance in 2021, the company implanted 25 out of 60 pigs with the wrong-sized devices. All the pigs were subsequently killed - an error that employees said could have been easily avoided with more preparation. Neuralink is also under investigation by the US Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe has been looking at the USDA’s oversight of Neuralink.
Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA, including a stint overseeing the office that reviews human-trial requests for brain implants, said the FDA does not typically inspect facilities as part of their review of applications for clinical trials. But he added this would have been warranted in this case, given the concerns around Neuralink’s animal experiments.
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