The FDA has just put a new end to the ambitions of a firm under pressure from its leader’s sometimes unwarranted impatience.
Definitely not a crazy love affair between Elon Musk’s companies and US regulators. After SpaceX, which was recently detained by the Federal Aviation Administration, it is Neuralink that has once again found itself in the crosshairs of the FDA, America’s public health police force. According to a Reuters investigation yesterday, the regulator rejected the company’s clinical trial application, citing safety risks.
Neuralink is committed to developing a brain-machine interface (BCI). In fact, this is a chip implanted in the brain that will allow you to directly control the nervous system. Initially, the goal was to make it a medical device to help people suffering from neurological disorders. In this way, the company hopes to cure Alzheimer’s disease, to enable some paraplegics to regain the ability to use their limbs … In short, this is a real medical revolution.
Musk clashes with medical sector imperatives
The worry is that Elon Musk is not a leader like the others. He is a hyperactive visionary who swears by total innovation. For him, technological progress is an unconditional priority. It doesn’t matter if you have to take significant risks.
This philosophy has played a decisive role in the success of the billionaire. This is especially true for SpaceX and Tesla. If the two titans reign supreme in their industries today, it is largely due to a pronounced taste for speed.
By investing billions in very ambitious concepts and putting considerable pressure on his troops, Musk has certainly played with fire, but he has also enabled electric vehicles and aerospace to take a huge leap forward.
On the other hand, if this questionable approach has paid off at Tesla and SpaceX, that doesn’t necessarily mean it’s valid in all cases. In the aerospace industry, for example, it’s okay to take a significant risk of failure, as long as you bear the financial consequences. But in the medical sector, the stakes are very different. This is about human life. And if that fails, a fat check and a flat apology to investors won’t be enough to turn the page.
Therefore, the development of a new medical device requires extremely strict specifications. Before you can even consider putting it on the market, you should already be able to prove that it works great and does not pose any security risk.
“This is not a toy”
As a rule, this is a very long and painstaking process. And that has already led the firm to miss several FDA deadlines. Thus, Neuralink was left behind; today its direct competitor, Synchron, leads the way in ICM.
And, as you might expect, this situation does not like the leader, who is fundamentally allergic to stagnation. Over the years, many more or less credible reports have pointed to Musk’s unfounded claims.
Obviously, he pushed his teams to get results as quickly as possible. This pressure would directly lead them to an unacceptable reduction in a medical context. “He can’t get it into his head that it’s not a car. We are talking about the human brain. This is not a toy,” an unnamed employee said in a Reuters report.
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“Dozens” of shortcomings
Suffice it to say that the FDA is watching the grain. And, according to Reuters, it is refusing to grant Neuralink a clinical trial license for the time being. In addition to the possible ethical issues that may arise, the agency would identify “dozens” of very specific shortcomings. Some of them are relatively minor, but others are much more important.
It all starts with a battery problem, which is a major problem in ICM development. The fact of implanting an object of this kind so close to the brain obviously poses a significant risk. If it fails, it can cause a short circuit or even an explosion, which can cause permanent neurological damage.
The FDA is also concerned about the procedure for implantation and extraction. It involves manipulating hundreds of small electrodes in specific areas of the brain. Therefore, it is necessary to make sure that the graft itself is not dangerous and to check that the electrodes will no longer move after the operation. It is also extremely important to be able to remove them without damaging the surrounding tissues.
Elon Musk will have to be patient
Ultimately, the regulator believes that Neuralink is still far from providing the necessary guarantees. “It appears that Neuralink does not have the mindset and experience to bring its product to market in the near future,” Kip Ludwig, former director of neuroengineering at the National Institutes of Health, told Reuters.
Recall that this is not the first case of dismissal of the FDA company. Neuralink has been wanting to move into human clinical trials for several years now. But already four times it was not possible to provide the necessary guarantees (in 2019, 2021, then twice in 2022).
She has already been the subject of several federal investigations. In particular, they concerned the treatment of guinea pigs or the alleged “irresponsible” handling of dangerous pathogens (see our articles here and there). In these cases, the methods of sulphurous billionaires also stood out. So let’s hope that Elon Musk can add water to his guilt, even if it means appointing a new leader, so as not to interfere with the development of this technology with almost unlimited potential.