Neuralink has received the green light from the US Food and Drug Administration

The human-machine medical interface could start its course in human trials

DrAfter a long back and forth, the FDA has finally approved Neuralink’s app to begin human trials on its brain-computer interface (BCI) prototype. Founded in 2016, Neuralink aims to market a platform for wide-ranging medical and therapeutic applications: from stroke and spinal cord injury rehabilitation, to prosthetic-limb controls, to the ability to “rewind or download memories into robots.” BCIs essentially translate the brain’s analog electrical impulses into the 0-1 figure that computers typically understand. Because the tool must be surgically installed in a patient’s brain, the Food and Drug Administration — which regulates such technologies — requires companies to conduct rigorous safety testing before granting them approval for commercial use. In March, the FDA denied Neuralink’s application to begin human trials, in part because of issues with animal testers and post-transplant issues.

More than 1,500 animals have died during Neuralink BCI development since 2018, according to internal documents obtained by Reuters in December. The U.S. Department of Agriculture (USDA) inspector general has since launched an investigation to better understand the question. The FDA’s reticence is also due to concerns about the design and function of the interface when implanted in humans. “The agency’s main safety concern was the device’s lithium battery; the potential for tiny, implanted wires to travel to other areas of the brain; and questions about the possibility and how to remove the device without harming brain tissue.” Even though Neuralink received FDA approval to start studies, but the company is not yet ready to start human trials.