Tech billionaire Elon Musk’s Neuralink, a US neurotechnology company that is developing implantable brain–computer interfaces, has secured Food and Drug Administration’s (FDA) approval for its first human trials that could help treat conditions like obesity, autism, depression, schizophrenia, etc.
Neuralink was struggling to secure a green light from FDA so that it could initiate its human clinical trials.
“The approval represents an important first step that will one day allow our technology to help many people,” said Neuralink in a tweet.
The company did not explain what were the aims of the study but it only stated that “it was not recruiting yet and more details would be available soon.”
According to the vision of the CEO of SpaceX Musk, brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enable web browsing and telepathy.
Musk was all over the news when he expressed his enthusiasm for the technology last year he was so confident in the devices’ safety that he would be “willing to implant them in his children”.
Since 2019, the 51-year-old CEO has on four occasions said that Neuralink would begin human trials. However, according to Reuters reports, the company only sought FDA approval in early 2022 and the agency rejected the application.
There were several concerns which FDA highlighted about Neuralink which were to be addressed before sanctioning human trials, according to the employees.
Major issues involved the device’s lithium battery, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
Founded in 2016, the neurotechnology company underwent several federal investigations.
US legislators in May urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
The Department of Transportation is separately investigating whether the company illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the US 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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