Neuralink, Elon Musk’s brain-on-a-chip company, says it has been given permission to begin research on humans.
In a tweet on Thursday, Neuralink said it had been cleared by the U.S. Food and Drug Administration (FDA) “to initiate our first-in-human clinical studies!”
It represents “an important first step that will one day allow our technology to help many people,” it said.
The company did not elaborate on the purpose of the study or when the trial would start, but said it has not yet recruited people.
Mr Muskwho claimed last year that the devices are so safe that he is happy to use his children as guinea pigs in the hope that they will one day help improve conditions, including obesityautism, depression and schizophrenia, and enabling web browsing and telepathy.
The billionaire has said Neuralink will begin at least four human trials since 2019, but the company only filed for FDA approval early last year.
The agency rejected it at the time — the main issues involved the implant’s lithium battery, the potential for its wires to travel within the brain, and whether the device could be safely removed without damaging brain tissue — and said it would wait to approve it. These issues need to be addressed before human trials.
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Founded in 2016, Neuralink has been the subject of multiple federal investigations.
In December last year, it was reported that it was accused of Alleged violations of animal welfare In its work, claims it has denied.
A total of 1,500 animals died over four years, leading to internal complaints that animal trials were being rushed, causing unnecessary suffering and death, according to a report.
Musk intensified the pressure to speed up development, leading to the need to repeat botched experiments, staff said.
In one reported case, 25 pigs were implanted with the wrong-sized device — a mistake that could have been avoided with more preparation, a source told Reuters.
Neuralink hopes the implant it’s developing will help paralyzed people walk again — and heal other neurological problems.
Earlier this week, Swiss researchers demonstrated the technology’s potential.
Paralyzed man from the Netherlands Able to walk simply by thinking – thanks to an implant that wirelessly transmits his thoughts to his legs and feet.