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Elon Musk’s Neuralink has received the green light from U.S. regulatory authorities to begin testing its pioneering brain implants in human subjects.

Neuralink announced this development on Thursday after obtaining clearance from the U.S. Food and Drug Administration (FDA) for their inaugural clinical trial on humans. The implant technology, created by Neuralink, aims to establish a direct interface between the human brain and digital devices.

Until now, Neuralink’s prototypes, roughly the size of a coin, have been trialed in monkeys, as shown in presentations by the startup. The implant procedure involves using a surgical robot that substitutes a portion of the skull with a Neuralink disc. The disc’s minute wires are then meticulously positioned within the brain. Musk revealed that this high-tech disc captures nerve activity and transmits it via a standard Bluetooth wireless signal to a digital device like a smartphone.

Musk has previously described the Neuralink implant as a seamless integration into the human body, noting that the implant comfortably fits within the skull. With the implant discreetly concealed under the hair, it remains virtually undetectable. In an earlier demonstration, Neuralink presented monkeys equipped with the implant successfully interacting with basic video games and controlling cursors on a screen. Similarly, the innovative technology has undergone preliminary testing stages in pigs.

Neuralink has yet to open up recruitment for its upcoming human clinical trial.


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