FDA approves Musk’s Neuralink to launch its first human clinical study

Author: Editorial
event 26.05.2023.
Foto: Shutterstock

Elon Musk’s brain chip company said Thursday that the U.S. Food and Drug Administration has given it the green light for its first human clinical trial, marking a key milestone following struggles to win approval.

Neuralink expressed enthusiasm over the FDA’s approval, recognizing it as a significant initial step toward utilizing their technology to help people.

While they did not provide further details about the study or recruitment at this point, they assured that more information would be revealed soon.

Elon Musk, the founder of Neuralink, envisions that brain implants could potentially treat various conditions such as obesity, autism, depression, and schizophrenia. Additionally, he believes these implants could enable activities like web browsing and telepathy. Musk’s confidence in the safety of the devices was evident when he stated his willingness to have them implanted in his own children, generating considerable attention.

Despite Musk’s previous predictions about commencing human trials, Neuralink only applied for FDA approval in early 2022. However, the application was rejected due to concerns raised by the FDA, including issues with the lithium battery, potential migration of implant wires within the brain, and the safe removal of the device without causing damage to brain tissue.

The company, established in 2016, has faced scrutiny from federal agencies. In response to lawmakers’ concerns, regulators were urged to investigate the composition of a panel overseeing animal testing at Neuralink, which may have contributed to flawed and rushed experiments.

Neuralink has faced allegations of mistreating its monkey test subjects, although it denies these claims. Furthermore, it is currently being investigated by the Department of Transportation for allegedly transporting hazardous pathogens on chips extracted from monkey brains without proper containment measures. Additionally, the U.S. Department of Agriculture’s Office of Inspector General is conducting an investigation into potential animal-welfare violations at Neuralink, which includes assessing the USDA’s oversight of the company.

Meanwhile, Neuralink is not the first company planning to implant a brain-computer interface in a human. Synchron received FDA approval to conduct trials in the US in 2021 and introduced the first US brain-computer implant in July of that year. Earlier this year, Synchron also published the results of a study involving four human patients in Australia.


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