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Funnily enough, FDA forbids Elon Musk's Neuralink human experiments

It's still coming soon ... just like it was in 2019, and 2020, and 2021, and 2022

Despite years of proclamations by Elon Musk that human tests were just around the corner, it turns out his Neuralink brain-implant startup has already asked the US Food and Drug Administration for permission to conduct human tests – and been rejected.

For those who can't recall, Neuralink is trying to make a chip that can be inserted into your skull and connected to your brain so that your neural signals can be accessed by a connected computer or phone. It's hoped this interface widget will open up a world of computer-brain interaction as well as help people with neurological issues communicate, see, and move again with the help of software. Developing such a thing will require testing on humans.

Seven current and former Neuralink employees told Reuters that Neuralink applied for human testing with the FDA in early 2022, and was given a list of dozens of reasons why the watchdog wasn't okay with the prospect.

The list of concerns, we're told, included worries over the fact that Neuralink implants are powered by lithium batteries, fears the wires used by the implants could migrate to different parts of the brain, and concerns over whether the implants could be removed without causing brain damage. Overheating issues were also reportedly cited. 

Those bugbears would need to be overcome before testing is allowed.

Neuralink has reportedly already been subjected to at least one US government probe for alleged mistreatment of animals during brain-chip experiments, with accusations against the biz last year ranging from sloppy surgical procedures to the use of toxic chemicals that destroyed the brains of some test subjects and killed others.

Neuralink insiders who spoke about the animal investigation last year reportedly called the surgeries "hack jobs," and in-house scientists expressed frustration at having to perform surgeries so quickly and in volume. 

The upstart is also being investigated by the US Department of Transportation for mishandling implants removed from deceased animals, which were allegedly transported and stored in unsecure containers despite containing traces of dangerous pathogens.  

In this most recent report, it's said Neuralink employees didn't share the FDA rejection paperwork, citing its legal confidentiality, and the news agency noted that as a private biz, Neuralink has no obligation to publicly disclose such regulatory interactions to investors or the public, which it hadn't prior to this news. 

Neither Neuralink nor the FDA responded to questions from The Register for this story.

So Elon, about those forecasts

In November - after Neuralink had been rejected for human tests by the FDA, but prior to public knowledge of that rejection - Elon Musk claimed that Neuralink chips could be in human brains "in about six months."

As we noted then, and again now, those proclamations should be taken with a grain of salt, especially considering Musk has said the exact same thing repeatedly since 2020 - not to say anything of this latest news.

According to FDA officials who spoke with the latest investigation into the brain biz, around two-third of human trial devices pass muster on the first application, while 85 percent are given approval on their second attempt. 

That first rejection, in other words, doesn't mean Neuralink won't make it to human trials, but FDA approval experts, like former program director for neural engineering at the US National Institutes of Health, Kip Ludwig, don't seem to think the company has what it takes to get there. 

Ludwig said that Musk's "well-known impatience" poses a challenge for the FDA approval process - which is delicate as it is - that might not work out in his or his startup's favor.

"Neuralink doesn't appear to have the mindset and experience that's needed to get this to market anytime soon," Ludwig said. ®

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