Neuralink aims to create a brain-computer interface (BCI), which would allow a user to control a computer simply by thinking about it. Such technology could be a boon to those with paralysis or another medical condition that affects mobility. It could also lead to novel ways to interact with technology for those without any physical disabilities at all. First, the company has to prove it can implant the chips without damaging the patient’s brain. Apparently, it’s not doing a great job of convincing the FDA of that.
The rejection, which Neuralink has not discussed publicly, allegedly cites myriad issues ranging from simple to severe. For example, the FDA wants the company to confirm that the ultra-fine electrodes, more than 1,000 of which will be inserted into the brain of Nueralink’s first test subjects, won’t migrate over time. In the same vein, Neuralink has yet to demonstrate that the implant can be removed without damaging the brain. The FDA also has concerns about the battery, which uses a unique wireless charging system demoed in the company’s monkey testing. The agency wants Neuralink to show that the lithium-ion cell has a very low chance of failure. If any component of the device were to stop working correctly, the battery could overheat and damage brain tissue.
Conversations with more than a dozen current and former Neuralink employees reveal a culture of animosity toward regulators, according to Reuters. They say that under Musk’s leadership, Neuralink sets aggressive timetables and views regulators as obstacles to reaching those goals. The NIH previously contacted the company, offering support as part of its BRAIN initiative (Brain Research through Advancing Innovative Neurotechnologies), but Neuralink declined. Employees say Musk was adamant about keeping the NIH at arm’s length for fear of increased public scrutiny. The government has since opened an investigation into Neuralink’s treatment of test animals.
The Neuralink implant will use tiny electrodes in the brain to read and interpret neuron activity.
Employees compare Musk’s approach to Nuralink with what he’s done at Tesla, which has rolled out new features like in-car games and self-driving capabilities that regularly draw the ire of safety advocates and regulators. However, creating an implantable medical device is different than building a car. Employees also gripe about Musk’s tendency to spend most of his time on other ventures, like SpaceX, Twitter, and Tesla. And yet, he’s one of the few constants at the company — most of Neuralink’s eight founders have left.
Even after all this, regulatory experts believe Neuralink will eventually work through the FDA’s concerns. BCI technology has the potential to change lives, which is why the NIH has been helping many Neuralink competitors navigate the process of developing a safe brain implant. Synchron, which is pursuing very similar technology to Neuralink, recently got approval to conduct its first human trials.
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