FDA has rejected Neuralink’s application for brain-computer interface human trials
The US Food and Drug Administration (FDA) has rejected Neuralink, a brain-machine interface application company owned by Elon Musk, from conducting human trials due to concerns about the potential impact of the lithium batteries used in its devices on the human body.
According to current and former Neuralink employees, the human trial application recently submitted by Neuralink has been rejected by the US FDA, as the use of lithium batteries in the implanted devices may pose risks such as leakage, combustion, and explosion, which could potentially harm the human body. The FDA also believed that Neuralink was unable to provide the technology to remove the implanted devices without damaging the human brain, thus determining that the trial posed a high risk.
On the other hand, the thin wires connecting to the gray matter of the brain in Neuralink’s device design may break or remain in the body during the removal or replacement process, which is one of the reasons why the FDA cannot approve this trial.
Prior to this, Neuralink had conducted experiments on animals such as pigs and monkeys. Although it successfully connected brainwave information in pigs, the monkey experiments resulted in numerous fatalities, which led to a great deal of social condemnation.
In December of last year, Elon Musk revealed that Neuralink would begin human trials in the next six months, leading many to speculate whether they had already obtained approval from the US FDA. However, as seen from this Reuters report, things did not go as smoothly as Musk had predicted.