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The Big Hurdle for Neuralink: Uncle Sam

A rendering of the Neuralink trials

When it comes to overcoming obstacles and making the impossible possible, few do it better than Elon Musk. His achievements at Tesla and at SpaceX are unparalleled by modern entrepreneurs. And he accomplished these feats despite an ocean of doubters believing he would fail. Understanding this, it becomes difficult to believe that his aspirations involving Neuralink won’t succeed. Musk’s brain-computer interface (BCI) device has been touted to usher in a new era of innovation. But thus far, Neuralink trials have failed to jump through the necessary hoops to advance. As a result, FDA approval of Neuralink has been stymied.

A cartoon of a monkey in the Neuralink trials
The Neuralink trials have hit a brick wall in the form of the US government–what’s next?

(Bold has been following the Neuralink project since the start–read up on it here.)

The problem pertaining to the FDA approval of Neuralink isn’t due to a lack of effort or investment. Musk has recruited top talent in an effort to promote innovation and outside-the-box ideas. But his approach to innovation combined with his leadership style isn’t congruent with the traditional FDA approval process. Even with several Neuralink trials involving animals already being conducted with success, safety remains in question. And cutting corners is not something that is looked upon very favorably when it comes to the greenlight for human trials. Given the situation, it’s not clear Musk can accomplish the same success with Neuralink that he has in other industries.   

“I definitely would never bet against him. If he has some bumps in the road with Neuralink, or any other thing, he’ll regroup and figure it out.” – Bob Nelsen, Co-founder of ARCH Venture Partners

Musk’s Neuralink System

In order to appreciate current barriers to the FDA approval of Neuralink, a closer look at the system itself is important. Simplistically, Musk’s system connects a computer to electrodes that then potentially send and collect signals to and from the brain. Brain signals may be used to help gain information, to communicate, or even evoke action. Likewise, computer databases can offer insights as well, enhancing knowledge, memory and awareness. Based on this, Musk has suggested that Neuralink trials could help address conditions like paralysis, autism, and mental illness. And he has also indicated it might be used for surfing the Internet or in performing telepathy. Of course, it’s the medical uses for which he hopes to obtain FDA approval for Neuralink.

The initial Neuralink system will consist of 1,024 electrodes, though more will be added over time. These electrodes will be receiving and sending information via tiny wires implanted into the brain. According to Musk, these wires, which are thinner than a human hair, will be placed via robotics within a few minutes. The robotics used can sew the threads into the tissue without hitting vessels or causing damage. And if they should need to be removed, Musk states this can also be easily achieved without risk. Of course, animal Neuralink trials proving this to be true are not available for public review. Likewise, review of available data to date has not yet facilitated FDA approval of Neuralink.

“The reason we don’t have a (BCI) device yet like Neuralink’s is not because no one has spent any money on it. It’s not because Elon Musk hasn’t thought about it enough. It’s because it’s a hard problem.” – Gene Civillico, Neurophysiologist

FDA Concerns Over Neuralink

When it comes to FDA approval of Neuralink systems, there are some notable barriers. Generally speaking, it’s not easy to attain such approval, especially when it comes to devices implanted within the skull. Neuropace, a company that received FDA approval for an implanted epilepsy device, spent 16 years in the process. Likewise, only 2/3 of those applying for approval receive it the first time around. Given this, it’s not surprising that Neuralink was recently rejected by the FDA for safety concerns. In addition to Neuralink trials being insufficient, the administration noted several specific issues that needed further attention.

A cartoon of a brain in the Neuralink trials
Can Elon Musk clear the “safety hurdle” the FDA has put in front of him?

The FDA identified several concerning areas when evaluating Neuralink’s application. The first involved concerns over its lithium battery and its durability. Questions arose regarding potential risks that might develop should the battery fail. Other issues pertained to the possible migration of the implanted wires. Naturally, this could cause problems as well. Finally, questions were asked about Neuralink’s removal and potential harm that this may cause. While Musk touts safety in all of these areas in animal Neuralink trials, the FDA was not convinced. This appears to be the main reason that the FDA approval of Neuralink didn’t occur.

“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon.” – Kip Ludwig, Former Program Director, NIH

Other Neuralink Woes

What FDA approval for Neuralink will bring
FDA approval for Neuralink isn’t happening anytime soon.

While the failed FDA approval of Neuralink is a recent setback, it hasn’t been the only one. reportedly, the U.S. Department of Agriculture is investigating the company regarding its treatment of lab animals. Expedited experiments involving pigs, sheep, and monkeys have raised questions about undue suffering and deaths. At the same time, The Department of Transportation has an open case against Neuralink as well. Some computer chips previously implanted within monkeys may have been transported without proper precautions. These are the kind of issues associated with Neuralink trials that further delay FDA approval.

The key issues linked to Neuralink’s problems with the FDA appear to stem from Musk’s leadership and approach. As has been seen with Tesla and SpaceX, Musk seeks disruptive innovation by pushing the envelope. Failure is not always viewed as mistakes made but instead as aggressiveness and as opportunities to learn. Naturally, this approach contrasts greatly with traditional safety-focused protocols that the FDA prefers. As a result, it’s not surprising that Musk tends to view regulators as barriers to innovation rather than necessary safeguards. And it’s why the FDA approval of NeuraLink may continue to experience rejections with subsequent applications.

Neuralink Is Down But Not Out

There’s no doubt that Musk will continue to forge ahead with Neuralink trials in an effort to gain approval. But time is of the essence as medical device competitors have gained some advantage already. Synchron, which approaches BCI device placement through less invasive means, gained FDA approval recently. Other companies are also moving forward in more traditional ways within this $6 billion industry. What remains to be seen is whether Musk can once again disrupt well-established protocols and processes with success. No one is counting him out, but gaining FDA approval of Neuralink may prove to be his toughest challenge yet.

 

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