Human Study For Elon Musk-Backed Neuralink Brain Chip Faced FDA Rejection 1 Year Ago, Company Still Working To Resolve Issues

  • FDA has reportedly blocked human trials for brain implants from Neuralink, a company founded by Elon Musk.
  • As per seven current and former employees, the brain chip company did not seek FDA permission until early 2022 – and the agency rejected the application, despite Musk being vocal on his intention to start human trials for the implant since 2019.
  • The agency outlined several issues, Reuters reported, citing the staffers, including:
    • The device's lithium battery
    • The potential for the implant's tiny wires to move to other areas of the brain.
    • Devices' removal without damaging brain tissue.
  • In a "Show & Tell" event held in December last year, Musk said that in less than six months, Neuralink would have its first device in a human.
  • A year after the rejection, Neuralink is still working to address the mentioned issues. 
  • Three staffers were not very confident that the company could resolve the issues – despite Musk's latest prediction at a Nov. 30 presentation that the company would secure FDA human-trial approval in 2023.
  • Most recently, the U.S. Department of Transportation said it is probing Neuralink for potentially illegal movement of hazardous pathogens and facing allegations of animal cruelty.
  • Neuralink is working to build a brain chip interface that can be implanted within the skull, which it says could eventually help the disabled move & communicate again and restore vision.
  • Photo via Wikimedia Commons
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