NEURALINK’S APPLICATION FOR HUMAN TRIALS HAS REPORTEDLY BEEN REJECTED

Musk has been one of the leading entrepreneurs of this century, and has single-handedly revolutionized electric vehicles and space travel. This does not take away the fact, however, that the Tesla, SpaceX, and Twitter CEO has often been overambitious with his announcements.

Despite multiple reassurances that Musk’s brain-machine interface company Neuralink will be beginning human trials, the company has failed to acquire the U.S. Food and Drug Administration’s (FDA) approval.

During the company’s last public presentation back in November, Musk highlighted the first two ambitious applications targeted by his “brain chip” – restoring vision in blinds and enabling paraplegics to move.

Despite already running behind schedule, Musk stated that he expected the device to be in human brains in six months.

Now comes the report from Reuters, which suggests that the firm still struggles to secure approval for human trials from the FDA.

What This Means: Musk either once again overestimated what his company had managed, or simply made promises he knew couldn’t be fulfilled. This is not the first time that the billionaire has faced this problem – take the new Roadster or even the Cybertruck, for example. Not to mention the expectations of a million Tesla Robotaxis by 2020

Musk originally said that Neuralink aimed to receive regulatory approval for human brain implants by the end of 2020, but ended up filing for permission from the FDA only in early 2022.

According to Reuters, the FDA outlines “dozens of issues” that need to be fixed before the product can be approved for human testing. The officials were worried about the device’s lithium battery zapping the brain’s mission-critical areas, as well as the fact that the device posed some danger when it came to its removal without damaging brain tissue.

The company has been collecting more controversy instead of desired results in recent memory. After being under the federal probe for potential animal welfare violations, Neuralink was reported to be moving hardware contaminated with herpes B and Staphylococcus.

Another report from Business Insider reported how these brain implants can cause strange cognitive changes, with reported cases of attempted suicide and overreliance on the brain implant.

“Nobody really agrees on what they mean, but we have cases where it’s clear that BCIs have induced changes in personality or expression of sexuality,” told Dr. Frederic Gilbert to BI.

Musk’s time is already spread so thin that the billionaire is taking 13-minute flights to jump between the headquarters of the 5 companies under his wing. Investors have also shown increasing concern over Musk’s interests, and whether he can handle all the projects he plans to oversee.

“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon,” stated Kip Ludwig, former program director for neural engineering at the U.S. National Institutes of Health (NIH).

While Neuralink has got its work cut out, its rival Synchron already received permission to start human trials last year. Be what it might, Musk has access to one thing that his competitors don’t – people who will be willing to get the implant out of love for the eccentric billionaire.