Reuters reports that Neuralink’s ambition is to provide a brain-computer interface orders of magnitude better than anything that exists today, giving the FDA headwinds. The agency reportedly rejected the company’s application to begin human testing last year.
According to well-sourced reports, the company bid for human testing in 2022 but was turned down citing a number of concerns. The “neural lace” that forms the implant can travel through the soft tissue of the brain. The device may overheat. Embedded batteries may fail. Failure, rejection, or removal under conditions of infection can damage the brain.
Such concerns are perfectly reasonable, and medical devices have been rejected because of potential safety issues because the creators didn’t test them properly or the regulators hoped they wouldn’t notice. I usually go back to work and try again in a year.
Maybe that’s what’s happening with Neuralink. Reuters sources say it doesn’t look like anyone is deafening their bad luck. However, some report that Musk is surprised by the slow pace of progress.
But the FDA is right to be alarmed. Neuralink not only proposes entirely new internal electronic systems and even new robotic implants, but also mentions cruelty in animal testing. Of course, this part of the process is in some ways unavoidably cruel, but there are guardrails to the ethics testers place on animals, and Neuralink reportedly crosses them.
Management left the company for whatever reason, and one of the co-founders actually left to found a new brain implant company, Precision Neuroscience, which raised $41 million.
Neuralink, like Musk’s other companies, is highly secretive, sharing progress only in the form of occasional, carefully curated events, making it difficult to measure progress and setbacks. But the video shows it being implanted in a seemingly happy monkey, and while promising, it’s no proof that the technology is ready for human testing. And after years of hearing “soon, soon” from companies despite seemingly receiving significant rejections from regulators, we begin to doubt.
Most companies operating in this space have been doing so for years, including FDA human testing and approval for use, without making the kind of promises Musk made on behalf of Neuralink. I was. This technology, in all its forms, represents a potential breakthrough for people with debilitating conditions, but it is fundamentally dangerous to put a foreign body into the brain, let alone a large amount of it. Companies wanting to pursue advanced applications for the implants must first prove that the implants are safe at a basic level, which is reportedly what the FDA is asking.
