Elon Musk’s prediction about Neuralink’s approval from the FDA was almost spot-on. After reportedly facing rejection in March, Neuralink has now received approval from the FDA to commence human trials of its prototype Link brain-computer interface (BCI). The announcement marks a significant milestone for Neuralink, a company founded in 2016 with the goal of commercializing BCIs for various medical and therapeutic applications, including stroke and spinal cord injury (SCI) rehabilitation, neural prosthetic controls, and even the potential to “rewind memories or download them into robots,” as promised by Neuralink CEO Elon Musk in 2020.
BCIs work by translating the brain’s analog electrical impulses into digital 1’s and 0’s, making them understandable to computers. Neuralink’s BCI involves the surgical implantation of hair-thin electrodes that delicately thread into the brain’s grey matter. Given the invasive nature of the procedure, the FDA, as the regulatory body overseeing such technologies, requires rigorous safety testing before granting approval for commercial use.
