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It turns out that Elon Musk’s FDA predictions were off by just a month. After he reportedly rejected the company’s offer in March, FDA Approves Neuralink’s Application A prototype Link Brain Computer Interface (BCI) will begin human testing 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 the control and performance of neural prostheses.Rewind memories or download them to robots,” Neuralink CEO Elon Musk promised in 2020. A BCI essentially converts the analog electrical impulses of the brain (monitoring the brain using hair-thin electrodes delicately inserted into the gray matter) into digital 1s and 0s that computers can understand. . Because it is surgically attached to a patient’s nose, the FDA, which regulates such technology, requires companies to undergo rigorous safety testing before approving it 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 discovered that more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The Inspector General of the United States Department of Agriculture (USDA) since we started investigating to those suspicions.
The FDA’s reluctance also stems from concerns about the design and functionality of interfaces when implanted in humans. “The agency’s primary 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.”