This crucial milestone signifies a major breakthrough for Neuralink, which had faced previous obstacles in obtaining regulatory clearance. Elon Musk had expressed his eagerness for human trials of Neuralink’s brain implant since 2019, as it holds immense potential for addressing debilitating conditions such as paralysis and blindness. However, despite its establishment in 2016, Neuralink only initiated the FDA approval process in early 2022. Unfortunately, their initial application was rejected by the agency, according to information shared by seven current and former employees with Reuters in March.
The FDA had raised several concerns that needed to be addressed before granting authorization for human trials, including issues related to the implant’s lithium battery, potential wire migration within the brain, and the safe removal of the device without causing damage to brain tissue. Amidst mounting pressure from US lawmakers urging regulators to investigate potential problems with Neuralink’s animal testing panel, which may have led to rushed and flawed experiments, the FDA’s recent approval comes as a significant development.
Neuralink has already been the subject of federal probes, with the US Department of Agriculture’s Inspector General conducting an investigation into possible violations of the Animal Welfare Act. Although the FDA’s approval represents a significant step forward, Neuralink clarified in a tweet that it is not yet prepared for a clinical trial. The company acknowledged the collaborative efforts between its team and the FDA, highlighting the milestone’s importance in clearing the path for their groundbreaking technology to benefit numerous individuals in the future.