Elon Musk’s Nueralink brain implant won’t be tested on humans anytime soon – the US Food and Drug Administration (FDA) has rejected the company’s request.
Nueralink employees told Reuters that the agency has identified dozens of issues the company needs to resolve before human testing is a key milestone for the product’s final approval.
Concerns include the device’s lithium battery; the potential for implantable microwaves to travel to other parts of the brain; The staff asked if and how the device could be removed without damaging the brain tissue.
Musk filed in early 2022, but employees say the company’s co-founder hasn’t fixed all the issues yet—but the billionaire announced that human trials will begin in six months in November .
The three employees said they doubted the company’s ability to resolve the issues quickly.
In an hour-long presentation on November 30, Musk said the company submitted “most of our paperwork” to the FDA without indicating any formal requests. But the six-month calendar seems confident.
Neuralink officials acknowledged that the FDA is raising safety questions in what they describe as an ongoing conversation.
The sources declined to provide Reuters with the agency’s written denial, which is a legally confidential document — but he mentioned it in an interview.
The company has been under scrutiny for the past few months as animal advocacy groups and former employees have raised the alarm about animal welfare violations.
Laboratory observations by staff conducting tests at UC Davis show that there are problems with these implants in animals that raise FDA concerns.
Five Nueralink sources said the FDA rejection lists dozens of things the agency calls “deficiencies” that the company needs to address before human trials.
The implant has tiny threads that carry electrodes mounted on the head, but according to six current and former employees, the Food and Drug Administration is concerned that the threads could travel to other parts of the brain.
Musk is said to have tried to fix the problem without luck by testing the implants on dozens of pigs.
Thirty years ago, Victor Krauthammer, a former FDA official, said that moving wires can cause inflammation in the brain, impair certain functions and damage blood vessels.
He and other experts say this problem can also hinder the effectiveness of the implant and require its removal.
“Stitches can cause damage because brains are very soft and very sensitive,” says Krauthammer. Said.
Brain device experts say the FDA’s concerns about the battery could also be serious.
Neuralink has proposed creating a new charging system for its devices that includes lithium batteries that can be charged remotely.
Six current and former Neuralink employees said the agency found that the company’s animal research should have shown the battery was less likely to fail.
All three brain transplant experts said that if any part of the device connected to the battery current fails, the current can damage brain tissue.
The US Food and Drug Administration also questioned whether the device could be removed without damaging brain tissue.
And at Nueralink’s presentation in November, officials acknowledged but downplayed the FDA’s concern.
Engineer Alex Wood-Thomas was asked about the potential risk of removing the device to implant an upgraded device in the future.
He told Reuters that because of the small size of the sutures, the scar on the brain was so small that it could easily be removed.
According to two Neuralink sources and internal discussions seen by Reuters, several employees objected, saying it was misleading and not supported by animal studies.
Wood Thomas declined to comment.
The US Food and Drug Administration (FDA) has also raised concerns that the device could overheat, which could damage tissue.
Industry and regulatory experts say Neuralink could address all of the FDA’s concerns.
Experts say the FDA may allow the company to move forward with a slower, phased trial if the company experiences minor issues with its device.
According to two people familiar with the discussions, the agency suggested that such a path could work for Neuralink, with fewer people transplanted initially and more months of testing.
But one source said the proposal frustrated Neuralink because it could delay progress toward final approval by the Food and Drug Administration.
News of the rejection comes after several investigations into Neuralink by the US Department of Transportation (DOT), most recently earlier this month.
The investigation comes in response to allegations by the Committee of Physicians for Responsible Medicine (PCRM) that Musk’s company unsafely packaged and transported implants from monkey brains that may have been contaminated.
The Daily Mail previously obtained Neuralink lab notes detailing how applying sealant to surgical holes caused the monkey’s brain to swell and bleed.
Source: Daily Mail
Source: Arabic RT
