Elon Musk’s FDA prediction has been out for almost a month. After reportedly denying the company’s overtures in March, the FDA approved Neuralink’s application to begin human trials of its prototype Link brain-computer interface (BCI) 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 capacity “to -rewind memories or download them to robots,” Neuralink CEO. Elon Musk promises in 2020. BCIs essentially translate analog electrical impulses in your brain (monitoring them with hair-thin electrodes delicately embedded in gray matter) into digital 1’s and 0’s that computers can understand . Because that BCI must be surgically installed in a patient’s noggin, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving the go-ahead. -its approval for commercial use.
In March, the FDA rejected Neuralink’s application to begin human trials reportedly in part because all the test animals continued to die after the BCI prototype was implanted. According to internal documents obtained by Reuters in December, more than 1,500 animals have been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture’s (USDA) Inspector General has since launched an investigation into the allegations.
The FDA restriction was also born out of concerns about the design and function of the interface when implanted in humans. “The agency’s major safety concerns involve the device’s lithium battery; the potential for tiny wires in the implant to migrate to other parts of the brain; and questions about whether and how to remove the device without harming the brain tissue,” current and former Neuralink employees said Reuters in March.
While Neuralink has received FDA approval to begin its study, the company is not yet seeking volunteers. This is the result of the incredible work of the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help more people,” Neuralink tweeted on Thursday. “Recruitment is not yet open for our clinical trial.”
