Initially, Musk’s application, submitted in March, was rejected by the FDA. Despite this setback, the regulatory body has now approved Neuralink’s chip for human testing.
Established in 2016, Neuralink aims to commercialize its proprietary BCI for diverse medical applications, from stroke rehabilitation to neural prostheses control. The BCI technology translates the brain’s electrical impulses into digital signals, enabling communication with computers through thin implanted electrodes. Due to the invasive nature of the procedure, the FDA demands rigorous safety assessments.
Neuralink’s approval for human trials is noteworthy, making it the first company to receive such authorization. Concerns raised by the FDA encompassed not only animal welfare but also potential risks to humans during the implantation process. The concerns specifically revolved around the device’s lithium battery, the possibility of wires migrating within the brain, and the complexities of device removal without damaging brain tissue.
An investigation into Neuralink’s practices, triggered by reports of over 1,500 animal deaths during the development of its BCI, is underway, led by the US Department of Agriculture’s inspector general.
While Neuralink has received FDA approval for research, the recruitment of volunteers for clinical trials has yet to commence. The decision, hailed as a significant step forward, represents the collaborative efforts of the Neuralink team and the FDA. The technology holds immense potential to assist numerous people in the future, once it moves past these critical testing phases.
