As it turns out, Elon Musk’s FDA prediction was only off by about a month. After reportedly denying the company’s proposals in March, the FDA approved Neuralink’s application to begin human testing of its Link brain-computer interface (BCI) prototype on Thursday.
Founded in 2016, Neuralink aims to commercialize BCIs in a wide range of medical and therapeutic applications, from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the ability to “rewind memories or download them.” in robots,” said the CEO of Neuralink. Elon Musk promised it in 2020. BCIs essentially translate your brain’s analog electrical impulses (monitoring them with hair-thin electrodes delicately inserted into that gray matter) into the digital 1’s and 0’s that computers understand. Because BCI must be surgically installed in a patient’s head, the FDA, which regulates such technologies, requires companies to undergo rigorous safety testing before approving their commercial use.
In March, the FDA rejected Neuralink’s application to begin human trials, reportedly in part because all the test animals kept dying after the prototype BCI was implanted in them. According to internal documents acquired by Reuters as of December, more than 1,500 animals had died in Neuralink BCI development since 2018. The US Department of Agriculture (USDA) Inspector General has since launched an investigation into those allegations.
The FDA’s reluctance was also due to concerns about the design and function of the interface when implanted in humans. “The agency’s primary safety concerns involved the device’s lithium battery, the possibility of the tiny implant wires migrating to other areas of the brain, and questions about whether and how the device can be removed without damaging the brain tissue,” said current and former Neuralink employees. said Reuters in March.
While Neuralink has obtained FDA approval to begin its study, the company is not looking for volunteers yet. This is the result of incredible work done by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.” Neuralink tweeted Thursday. “Recruitment is not yet open for our clinical trial.”
