FDA clears Neuralink chip for 2nd human trial, company says wire issue fixed

The U.S. Food and Drug Administration (FDA) gave Neuralink the green light to implant its brain chip in a second human patient. The decision came just one week after the Elon Musk-backed startup admitted many of the device’s wires disconnected from its first patient’s brain.

Neuralink made several changes to the device and how it is implanted to fix that issue before resubmitting its work to the FDA, according to The Wall Street Journal.

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The device allows an individual to control digital devices using brain signals. Neuralink designed the chip specifically to help quadriplegic people. More than 180,000 Americans are quadriplegic, which means their paralysis prevents them from using all four limbs. The chip promises to improve their quality of life.

The adjustments to the first chip include embedding the ultra-thin connector wires deeper into the brain’s motor cortex to enhance stability and function.

The changes address issues experienced by Nolan Arbaugh, the first chip recipient. The wires in his chip became detached and temporarily resulted in a loss of functionality. Neuralink reported it stabilized the remaining threads and updated the software to improve the chip’s capabilities.

Arbaugh can now control a laptop and is able to use it to play games and browse the internet. He participates in research sessions for upwards of eight hours per day, and frequently uses it for personal activities on the weekends. Data showed Arbaugh used the device for nearly 70 hours in a week, thanks to updates in the technology.

“The games I can play now are leaps and bounds better than previous ones,” Arbaugh said. “I’m beating my friends in games that as a quadriplegic I should not be beating them in.”

Neuralink said ongoing adjustments and user feedback are critical. The company hopes to implant the updated chip in 10 additional patients in 2024.

Neuralink is actively accepting applications and plans to expand trials to Canada and Great Britain. The company hopes to open applications for both of those counties in the coming days.