Apparently, Neuralink founder Elon Musk knew for a year that the US Food and Drug Administration (FDA) would not allow the company to use its brain chips in humans. However, just three months ago, he announced that human testing would begin in the spring. This seems unlikely, as the FDA cited serious concerns about the implant, such as the risk of lithium battery leakage, the possibility of the implant’s tiny wires migrating to other areas of the brain, and the need for an explanation of how the device can be safely removed without damaging brain tissue. These issues are significant and may not be resolved in six months, casting doubt on Musk’s promise of human testing this spring.
According to Reuters, Neuralink applied to the FDA for permission to begin human subject testing in early 2022. However, the FDA rejected the application, citing several potential dangers that needed to be addressed before granting approval. Despite this, neither Neuralink nor Musk informed investors or the public of the FDA’s decision, which is not legally required.
While Musk may have made ambitious predictions for the technology in the past, the FDA’s negative report on the brain implant suggests that this is not a social network or a car, where Musk can make predictions without regulatory consequences. Implanting a chip in the brain requires a high level of scrutiny, and meeting the FDA’s demands may pose a challenge for Neuralink. It remains to be seen whether Musk can deliver on his promise to start human trials this spring.