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Be the first with the news that moves the marketElon Musk’s Neuralink, a brain implant firm, has received regulatory approval for U.S. human trials.
Neuralink tweeted the following on Thursday,
“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 technology to help many people.
Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”
The health tech company, co-founded by Musk in 2016, intends to use chips to treat paralysis and blindness, as well as help disabled people access computer and mobile technology.
The chips interpret brain signals, recognize patterns in the activity, and relay the information to devices via Bluetooth to turn them into actions.
Prototype testing has involved macaque monkeys, including one by the name of Sake, who was shown typing and playing the Pong video game aided by the implant.
The news comes amid an ongoing investigation into Neuralink by the US Department of Agriculture concerning animal welfare. Company testing has allegedly killed some 1,500 animals – including rats, mice, sheep, pigs and monkeys – since 2018.
An attempt at FDA approval in early 2022 was rejected due to issues involving the device’s lithium battery, the risk of implant wires migrating in the brain, and the questionable safety of extracting the device without damaging brain tissue.
Neuralink most recently applied to the FDA in December for the human trials, allowing patients to enroll in future tests a few weeks later.
Musk has stated that he is confident enough to install implants in his own children, and that the technology may ease concerns about human displacement at the hands of artificial intelligence.
That said, the expert consensus is that Neuralink’s brain chips still require extensive technical and ethical testing before attaining market-wide availability.
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