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The U.S. Food and Drug Administration (FDA) approved Elon Musk’s Neuralink to implement its brain chip in a second individual. This authorisation follows the company’s proposed solutions to address the challenges identified during the initial testing phase involving participant Norland Arbaugh.
Neuralink’s proposed fixes involve embedding some of the device’s ultrathin wires deeper into the brain to address the functionality problems experienced by Arbaugh after his implantation, reports WSJ.
Arbaugh, a quadriplegic who initially regained significant abilities through the Neuralink implant, faced challenges when the device’s functionality declined a month after surgery. Most of the threads implanted in his brain had loosened, hindering the device’s ability to read electrical signals for translating thoughts into actions.
“I thought that I had just gotten to, you know, scratch the surface of this amazing technology, and then it was all going to be taken away,” said Arbaugh.
Neuralink told Arbaugh that despite the challenges, around 15% of the threads in his brain have stabilised. Additionally, the company’s software enhancements have successfully restored several functionalities of the device.
With the FDA’s clearance, Neuralink is now set to implant the device in another participant, which is scheduled for June. While more than 1,000 quadriplegics have expressed interest in Neuralink’s patient registry, fewer than 100 meet the criteria for participation in the study.
Neuralink proposed that they implant the chip up to eight millimetres into the motor cortex compared to the previous three to five millimetres. The company aims to implant its device in 10 individuals this year, with plans to diversify the recipient pool for a comprehensive behavioural study. However, the company faces a challenge as its patient registry currently skews towards white and male participants.
The company also plans to submit applications to regulators in Britain and Canada to start trials. As of now, the patient registry is open in Canada and will open in Britain in the coming months.
Last week, reports came out that despite knowing about potential wire retraction issues from animal testing, Neuralink decided to move forward with human trials.
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