Federal agency reportedly said the company needed to address ‘dozens of issues’
Vishwam Sankaran
The US Food and Drug Administration (FDA) had reportedly rejected a proposal by Elon Musk’s brain chip company Neuralink to begin testing its implants on humans.
Neuralink has been working on chips that can be implanted into the skull for the possibility of a computer-brain interface, some purposes of which could be to help restore vision in the blind and even help paralysed people walk again.
When Neuralink applied for human testing with the FDA in early 2022, the watchdog rejected the proposal and said there were “dozens of issues the company must address,” Reuters reported, citing current and former employees at the startup.
Concerns raised by the FDA included worries that Neuralink implants are powered by lithium batteries and fears that wires used in the implants may potentially “migrate” to different parts of the brain.
The FDA also reportedly raised concerns about whether the Neuralink implants could be removed without causing brain damage.
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Employees cited by Reuters didn’t share the FDA rejection paperwork from November 2022 due to legal implications.
Mr Musk had said in November last year that the company expected to begin clinical trials in humans in “about six months”.
Previously in 2021, replying to a Twitter user who claimed to be paralysed in a car accident, Mr Musk said Neuralink was in “close communication with the FDA”, adding that, “if things go well”, the company “might be able to do initial human trials later this year”.
Then he tweeted in November 2022 that he was confident the Neuralink device was “ready for humans” and said the timing for beginning trials in people was a “function of working through the FDA approval process”.
“We want to be extremely careful and certain that it will work well before putting a device into a human but we’ve submitted I think most of our paperwork to the FDA and probably in about six months we should be able to upload Neuralink in a human,” the multibillionaire had said at a much-awaited “show and tell” event.
The company has so far unveiled the working of its technology in monkey models, including one demonstration of a nine-year-old macaque learning to play the 1970s video game classic Pong in return for a banana smoothie reward.
But following complaints by animal rights groups, including the Physicians Committee for Responsible Medicine (PCRM), criticising the company’s “inadequate care” of its research monkeys, Neuralink was also subjected to at least one US government probe over alleged mistreatment of its animals.
Citing public records, PCRM also pointed out that Neuralink transported “contaminated” devices removed from the brains of “infected” monkeys without safely packaging them.
In a blog post, Neuralink defended the use of monkeys in its research, adding that “all novel medical devices and treatments” must be tested on animals before they can be trialled on humans.
Nearly 1,500 monkeys, pigs and mice have been killed undergoing Neuralink testing since 2018, Reuters previously reported.
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“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon,” Kip Ludwig, former programme director for neural engineering at the US National Institutes of Health, told Reuters.
Neuralink could not be immediately reached for comment by The Independent.
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