This development comes on the heels of the company's successful efforts to rectify the issues that arose with its first patient, Noland Arbaugh, a 30-year-old quadriplegic.
Arbaugh, who lost mobility below his shoulders following a 2016 car accident, had the Neuralink chip implanted in his brain in January. The device, roughly the size of a quarter, is equipped with a battery and 64 external threads, each thinner than a human hair. It is installed into the brain's motor cortex to relay neural signals.
Despite initial setbacks, Arbaugh has been able to control a computer cursor using only his thoughts, play games, and communicate with friends. However, complications arose when the implant's minuscule wires, which are thinner than a human hair, retracted from Arbaugh's brain. This resulted in a reduction in the number of electrodes available to measure brain signals.
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"I was on such a high and then to be brought down that low. It was very, very hard," Arbaugh told The Wall Street Journal about his reaction to losing some of the device's capabilities. "I cried."
Neuralink had anticipated the possibility of wire retraction from its animal testing conducted prior to US approval last year. The company deemed the risk low enough to not warrant a redesign, according to a report by Reuters.
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In response to the issue, Neuralink made changes to restore the implant's ability to monitor Arbaugh's brain signals. These modifications included adjusting its algorithm to increase sensitivity. The company also informed Arbaugh that 15% of the threads in his brain remain in place and that software tweaks have enabled him to regain many of the device's capabilities.
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Neuralink's proposed solution to the wire retraction issue, which it presented to the FDA, involves inserting the implant deeper into the brain's motor cortex. In Arbaugh's case, the implant was placed between three to five millimeters deep. The FDA has agreed to Neuralink's proposal for future patients to have the implant embedded eight millimeters into the motor cortex.
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The Wall Street Journal first reported the FDA's approval of Neuralink's proposal on Monday. The FDA was aware of the potential issue with the wires because Neuralink shared the animal testing results as part of its application to begin human trials, according to Reuters.
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Neuralink's ambitious plans extend beyond the second patient. The company aims to have 10 people implanted with the technology by the end of the year. Over 1,000 quadriplegics have registered in hopes of being the second person to receive the brain implant, according to The Wall Street Journal. Neuralink intends to narrow down the list to fewer than 100 candidates and make a final decision on a patient sometime next month.
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Despite the majority of applicants being white and male, the company is striving for a diverse patient pool. Neuralink is also seeking regulatory approval from authorities in Canada and the UK. Last week, Musk announced on his social media platform, X, that Neuralink was still accepting applicants.
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