FDA Denies Human Trials for Elon Musk’s Neuralink Brain Implants over Safety Concerns

The FDA has denied human testing trials for Neuralink, Elon Musk’s brain-computer interface company. The FDA reportedly raised numerous “deficiencies” with Neuralink’s plan, including safety concerns over the lithium batteries that power the brain implant.

According to a recent report from Reuters, the FDA has rejected Neuralink’s application for human trials in early 2022, which has caused a delay in the company’s ambitious timeline. According to Reuters, the FDA raised numerous issues with the device, which Neuralink staff are still attempting to resolve.

Neuralink has lagged behind its competitors due to a lack of public timelines and progress reports. Musk stated in 2019 that the company planned to begin human trials by the end of 2020 with the aim of curing dementia and spinal cord injuries. In November 2022, Musk stated that the company was still about six months away from conducting human trials in a presentation which displayed little technological advancement.

Breitbart News reported at the time:

Bloomberg reports that Neuralink, Elon Musk’s brain-computer interface firm, said at a Wednesday evening event at its headquarters that it plans to begin putting its coin-sized computing brain implant into human patients in six months. This news comes despite the fact that an overwhelming majority of America think slapping a computer chip inside the human brain is a terrible idea for society.

Musk said that Neuralink’s device, which has been refined over the past years, would be implanted into people using a robot that carves out a piece of their skull and attaches the device to their brain. Discussions with the FDA mean that the company can plan to begin it’s first human trials in the next six months, he said.

In addition to working on a brain-computer interface, Musk revealed that his company is working on spinal implants that might one day restore mobility to people with paralysis. He also revealed that his firm is working on an ocular implant to restore human vision or improve it. Despite the continued hype from Musk, recent reports show that Neuralink is a company in chaos.

Neuralink employees who spoke with Reuters were not confident that they would receive FDA authorization for trials by March 7, 2023, with one employee referring to it as a “gamble,” despite a company document from last fall indicating that they expected approval by that date.

Numerous “deficiencies” that Neuralink must resolve before its product can be used on human brains were reportedly listed in the FDA’s rejection. According to staff members who read the FDA’s document and spoke with Reuters, some issues were minor, but others were significant. The FDA expressed concerns regarding the safety of the lithium rechargeable batteries Neuralink suggested be used for its product. The FDA stated that in order to demonstrate that the battery was extremely unlikely to malfunction and potentially harm brain tissue, the company would need to conduct animal testing.

The FDA also expressed serious concerns about the potential for the implant’s tiny wires to migrate into the brain, which could result in inflammation, blood vessel ruptures, and impaired brain function. The FDA also questioned whether the device could be removed from users’ brains without harm.

While the FDA’s concerns may be rectified, Neuralink will still need to conduct more animal testing, which current and former employees claim has been done in an irresponsible manner in the past. Some claim that the company mistreated research animals, killing more than was required and performing “hack job” operations to meet Musk’s tight deadlines.

The Department of Agriculture has opened an investigation into Neuralink regarding potential animal welfare violations. In addition, the Department of Transportation is looking into allegations that Neuralink shipped brain implants taken from research monkeys infected with a number of dangerous pathogens in violation of federal transportation laws.

No matter what happens between Neuralink and the FDA, the vast majority of Americans believe brain implants are a very bad idea.

As Breitbart News previously reported:

The vast majority of U.S. adults surveyed by Pew Research, around 78 percent, stated that they would not personally want a brain chip implant even if they were readily available. Only 13 percent of those that responded to the survey said that they thought the types of implants developed by Nueralink and other biotech companies seem like a good idea for society.

56 percent of those polled by Pew stated that they believe technology like Neuralink would be actively bad for society. A second majority of 57 percent worried that the widespread use of brain interfaces could potentially widen the gap between high and low-income Americans. Less than a quarter of all surveyed believe that even if the tech was widely available it would actually improve human decision-making.