In a groundbreaking development, the US Food and Drug Administration (FDA) has granted Neuralink, a brain-computer interface company founded by Elon Musk, approval to conduct human trials, despite ongoing investigations into violations of the Animal Welfare Act.
Neuralink, established in 2016, aims to commercialize its proprietary brain-computer interface (BCI) for various medical applications, from stroke rehabilitation to controlling neural prostheses. The technology works by translating the brain’s electrical impulses into digital signals, allowing communication with computers through implanted electrodes. Due to the surgical nature of BCI, the FDA mandates stringent safety evaluations.
The FDA’s decision comes after initially rejecting Musk’s application due to concerns about animal deaths during BCI prototype implantation and potential risks related to the device’s design. Internal documents revealed that over 1,500 animals died during Neuralink’s BCI development since 2018, prompting an investigation by the U.S. Department of Agriculture’s inspector general.
Key concerns revolved around the device’s lithium battery, the possibility of wires migrating within the brain, and challenges related to safe device removal without damaging brain tissue. Despite these challenges, the FDA has now permitted Neuralink to proceed with human trials, making it the first company to receive such approval.
Neuralink’s CEO, Elon Musk, stated in 2020 that the technology could potentially “rewire memories or upload them to robots.” While the FDA’s approval is a significant milestone, the company has yet to commence volunteer recruitment for clinical trials.
Neuralink expressed gratitude for the FDA’s decision, emphasizing the collaborative efforts between the company and the regulatory body. This approval marks a pivotal step toward a future where BCI technology may assist numerous people. However, the controversial circumstances surrounding the approval underscore the ethical and scientific complexities inherent in this cutting-edge field.
