Neuralink, Elon Musk's neurotechnology company, recently obtained approval from the Food and Drug Administration (FDA) to conduct a clinical study of brain implants in humans. This marks the first in-human clinical study for the company.
"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 technology to help many people," the company said in a statement. "Recruitment is not yet open for our clinical trial. We'll announce more information on this soon."
Project officials said they are "currently focused on giving people with quadriplegia the ability to control their computers and mobile devices with their thoughts."
Musk has been insisting that his devices are safe and could help solve conditions, such as obesity, autism, depression and schizophrenia. The tech mogul even volunteered his kids as guinea pigs.
The FDA initially turned down the company in 2019 as there are major issues involving the implant's lithium battery, the possibility of its wires migrating within the brain and whether the device could be safely removed without damaging brain tissue.
According to reports, the implant prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys. With the help of a surgical robot in a demonstration back in April 2021, a piece of the skull was replaced with a disk and wires were strategically inserted into the brain of a nine-year-old macaque named Pager.
Musk said the disk registered nerve activity, relaying the information via a common Bluetooth wireless signal to a device such as a smartphone. "It actually fits quite nicely in your skull," Musk said during a prior presentation. "It could be under your hair and you wouldn't know." The technology has also been tested on pigs whose legs can be controlled remotely by a computer.
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Meanwhile, the Department of Transportation announced in February that it is investigating whether the company had transported potentially dangerous pathogens when removing the brain chips from monkeys' brains without proper measures to contain them, which would be in violation of federal law.
Another probe by the U.S. Department of Agriculture's (USDA) Office of Inspector General was conducted for potentially violating the Animal Welfare Act. The probe was also checking on how the USDA has been overseeing the company.
A Reuters report in December 2022 indicated that California-based Neuralink, which employs more than 400, has raised at least $363 million and already killed about 1,500 animals, including more than 280 sheep, pigs and monkeys for research since 2018.
Musk has plenty of competitors in hijacking human brains
Musk's company aims to supercharge human capabilities, treat neurological disorders and ultimately achieve a symbiotic relationship between humans and artificial intelligence. However, Neuralink is not the sole company working on similar brain-machine or brain-computer interface research.
Its archrival Synchron announced in July 2022 that it had implanted the first human brain-machine interface in the United States. Its implant version does not require cutting into the skull to install it, unlike Neuralink's. (Related: Neuralink competitor Synchron launches human trials for first commercial brain computer interface.)
Another implant project, but this one designed only for research purposes, is from the company Blackrock Neurotech. It has also received FDA approval for human testing. Its founder is Musk's Neuralink co-founder Max Hodak, who split with the Twitter CEO and raised venture capital for his own project at a startup called Science.
Other companies seeking to make a play in the sector include BrainCo, Kernel and CTRL-Labs, now a part of Meta's virtual reality division.
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Watch the video below that talks about the FDA approval of Neuralink's brain chips for human testing.
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