Neuralink receives FDA clearance to begin human trials of its brain-computer interface

It turns out that Elon Musk’s FDA forecast was off by just a month. After reportedly rejecting the company’s proposals in March, the FDA approved Neuralink’s application to begin human trials 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 control to “the ability to retrieve memories or download them into robots,” it said. CEO of Neuralink. Elon Musk promised in 2020. BCIs basically translate analog electrical impulses from your brain (by tracking it using hair-thin electrodes that are delicately stuck into that gray matter) into digital 1s and 0s that computers understand. Because that BCI must be surgically implanted in the patient’s noggin, the FDA, which regulates such technology, requires companies to perform rigorous safety testing before it can be approved for 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 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 (USDA) inspector general has since launched an investigation into the allegations.

The FDA’s reluctance also stemmed from concerns about the interface’s design and function in humans. “The agency’s primary safety concerns were the device’s lithium battery, the migration of the implant’s tiny wires to other parts of the brain, and questions about whether and how to remove the device without damaging brain tissue,” current and former Neuralink employees said. told 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 many people.” Neuralink tweeted Thursday. “Recruitment for our clinical trial is not yet open.”

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