Turns out, Elon Musk’s predictions from the Food and Drug Administration have only been off for about a month. After the company’s overtures were rejected by the US Food and Drug Administration in March, the FDA approved Neuralink’s app to begin human trials on its brain-computer interface (BCI) prototype on Thursday.
Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications – from stroke and spinal cord injury (SCI) rehabilitation, to controls in neuroprosthetics, to the ability to “return or download memories into robots.” Neuralink CEO Elon Musk promised in 2020. BCI essentially translates the analog electrical impulses of your brain (monitored using hair-thin electrodes threaded neatly into that gray matter) into the numbers 1 and 0 that computers understand. Because a BCI must be surgically installed in a patient’s head, the Food and Drug Administration—which regulates such technologies—requires companies to conduct rigorous safety testing before granting approval for commercial use.
In March, the FDA denied Neuralink’s application to begin human trials, reportedly in part because test animals died after implanting the prototype BCI. According to the internal documents that I obtained Reuters In December, more than 1,500 animals were killed in the development of Neuralink BCI since 2018. Since then, the United States Department of Agriculture (USDA) Inspector General has launched an investigation into the allegations.
The FDA’s reticence was also born out of concerns about the design and function of the interface when implanted in humans. “The agency’s main safety concerns included the device’s lithium battery; the potential for the implant’s microwires to travel to other areas of the brain; and questions about whether and how the device could be removed without damaging brain tissue,” according to current and former Neuralink employees. Tell Reuters in March.
While Neuralink has received FDA approval to begin its study, the company is not yet looking for volunteers. This is the result of the amazing work the Neuralink team has done in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many more people.” Tweet Neuralink on Thursday. “Recruitment is not yet open for our clinical trials.”