Elon Musk’s brain-implant company Neuralink on Thursday said it had received the US Food and Drug Administration’s (FDA) approval to launch its first in-human clinical study.
The company announced the decision on Twitter, saying the approval “represents an important first step that will one day allow our technology to help many people.”
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
— Neuralink (@neuralink) May 25, 2023
Elon Musk’s Neuralink envisions brain implants could cure a range of conditions
The goal of the company is to develop chips that can be implanted in people’s brains to treat neural disorders.
The implants may one day be powerful enough to put humanity on a more even footing with possible future superintelligent computers.
In public comments over the years, Elon Musk has detailed a bold vision for Neuralink: both disabled and healthy people will pop into neighborhood facilities for speedy surgical insertions of devices with functions ranging from curing obesity, autism, depression or schizophrenia to web-surfing and telepathy.
Eventually, Musk has said, such chips will turn humans into cyborgs who can fend off the threat from sentient machines powered by artificial intelligence.
“I could have a Neuralink device implanted right now, and you wouldn’t even know,” Musk said recently.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials.
In March 2023, FDA turned down a bid from Neuralink to begin human trials. In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing.
The agency’s major safety concerns at the time involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.
Apparently, the doubts expressed by FDA were addressed by Neuralink in the meantime.
Neuralink isn’t the only company in the field of what is known as the brain-computer interface or BCI industry.
Scientists across different companies are working to develop artificial intelligence for the brain so people with severe spinal injuries, for example, can talk or type using brain waves.
Meta CEO Mark Zuckerberg bought CTRL-labs, a startup developing non-invasive neural interfaces, in 2019.
The startup was folded into Facebook’s Reality Labs, whose goal is to “fundamentally transform the way we interact with devices.”
While there are brain-computer interfaces in gaming, Neuralink hopes to be the first to improve cognitive functioning.
Neuralink probed in the US
Neuralink, founded in 2016, has been the subject of several federal probes, Reuters reports.
In May, U.S. lawmakers 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 probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the U.S. 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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