It turns out that Elon Musk’s FDA predictions were off by just a month. After reportedly rejecting the company’s offer in March, the FDA on Thursday approved Neuralink’s application to begin human testing of a prototype Link Brain Computer Interface (BCI).
Founded in 2016, Neuralink is using BCIs in a wide range of medical and therapeutic applications, from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic control, to the ability to “rewind or download memories to robots.” Aiming to commercialize it (Neuralink CEO) Elon Musk promised in 2020. A BCI essentially converts the brain’s analog electrical impulses (monitored by hair-thin electrodes delicately inserted into the gray matter) into digital ones and zeros that computers can understand. Because BCIs must be surgically attached to a patient’s nose, the FDA that regulates such technology requires companies to undergo rigorous safety testing before approving them for commercial use.
In March, the FDA rejected Neuralink’s application to initiate human trials, in part because all experimental animals continued to die after implanting prototype BCIs. According to an internal document obtained by Reuters In December, it was revealed that more than 1,500 animals had been killed in developing the Neuralink BCI since 2018. The U.S. Department of Agriculture (USDA) Inspector General has since launched an investigation into these allegations.
The FDA’s reluctance also stems from concerns about the interface’s design and functionality when implanted in humans. “The agency’s main safety concerns include the device’s lithium battery, the potential for tiny wires in the implant to travel to other areas of the brain, and whether and how the device can be removed without damaging brain tissue. It included questions about,” said current and former Neuralink employees.Said Reuters March.
Neuralink has received FDA approval to begin the study, but the company has yet to recruit volunteers. This is the result of a great job by the Neuralink team working closely with the FDA, and represents an important first step towards one day enabling our technology to help many people. ” Neuralink tweeted Thursday. “Our clinical trial recruitment has not yet begun.”
