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.
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.
While Neuralink has now secured FDA approval to commence its study, the company is not actively seeking volunteers at this stage. In a tweet on Thursday, Neuralink expressed their gratitude to the FDA and the collaborative efforts of the Neuralink team, describing the approval as an important first step toward a future where their technology can assist numerous individuals. They clarified that recruitment for their clinical trial has not yet begun.
The FDA’s approval for Neuralink to proceed with human trials signals a significant advancement in the field of brain-computer interfaces. As Neuralink continues its pioneering work, the potential for BCIs to revolutionize medical treatments and restore functionality to those with neurological conditions becomes increasingly promising.
