In March, the FDA initially rejected Neuralink’s application for human trials, reportedly due in part to concerns arising from the deaths of test animals that had undergone the BCI implantation. Internal documents obtained by Reuters in December revealed that over 1,500 animals had been sacrificed during the development process of the Neuralink BCI since 2018. The United States Department of Agriculture’s (USDA) Inspector General has launched an investigation into these allegations.
The FDA’s hesitation was also influenced by apprehensions surrounding the design and functionality of the BCI when implanted in humans. Former and current Neuralink employees informed Reuters in March that the FDA’s primary safety concerns were related to the device’s lithium battery, the possibility of the implanted wires migrating to unintended areas of the brain, and the potential damage to brain tissue during the removal process.
