According to Reuters news reports, the U.S. Food and Drug Administration (FDA) has rejected the application of Neuralink, a brain-computer interface application company owned by Elon Musk.human trials, because there are still concerns that the lithium batteries used in its devices may cause harm to the human body.
Reuters obtained statements from current and former Neuralink employees, stating that Neuralink's application for human trials has been rejected by the U.S. Food and Drug Administration. The reason is that the lithium batteries used in the implanted device may have risks such as leakage, combustion and explosion, which may have harmful effects on the human body. At the same time, it is also believed that Neuralink cannot provide the technology to remove the implanted device without damaging the human brain, so this trial is considered to be highly risky.
On the other hand, in the device design proposed by Neuralink, the wires connected to the human brain's gray matter are extremely thin, but there is a risk of them breaking or remaining in the human body during the removal and replacement process. This is also one of the reasons why the US Food and Drug Administration was unable to approve this trial.
Prior to this, Neuralink had conducted experiments on pigs, monkeys and other animals. Although it claimed to have successfully connected brain wave information in pigs, the experiments on monkeys caused the deaths of many subjects, and therefore faced a lot of social condemnation at the time.
In December last year, Elon Musk revealed that Neuralink would begin human trials within the next six months, which led many to speculate whether it was confident of obtaining approval from the U.S. Food and Drug Administration. However, judging from the Reuters news report, it is clear that things are not going as smoothly as Elon Musk said.
