The Food and Drug Administration has given Elon Musk’s brain chip company, Neuralink, approval to implant its device into a second patient as early as next month. The agency was satisfied with the company’s proposals to fix errors found in the first patient, Noland Arbaugh, a quadriplegic who has been able to control a computer cursor using his thoughts and communicate with friends.
Earlier this month, Neuralink disclosed that the implant’s tiny wires had retracted from Arbaugh’s brain, resulting in fewer electrodes to measure brain signals. Despite knowing of this potential issue from animal testing, the company did not believe a redesign was necessary. Neuralink made changes to restore the implant’s monitoring abilities by modifying its algorithm to be more sensitive.
Arbaugh, who lost movement below the shoulders due to a 2016 accident, had the chip surgically implanted into his brain in January. However, weeks later, some of the wires retracted from his brain, impacting his capabilities and causing him emotional distress. Neuralink assured Arbaugh that 15% of the wires remained intact and made software changes to help him regain most of the device’s features.
Neuralink informed the FDA of its plans to address the issue by implanting the device deeper into the brain’s motor cortex in future patients. The agency approved the proposal and has been made aware of the potential issues with the wires through the company’s animal testing results. Over 1,000 quadriplegics have signed up for the patient registry in hopes of receiving the brain implant, but Neuralink plans to narrow down the candidates to less than 100 before making a final decision next month.
Musk announced on social media that Neuralink is still accepting applicants and aims to have a diverse patient pool, although most current applicants are white males. The company is working towards having 10 individuals implanted with the technology by the end of the year and is also seeking regulatory approval from authorities in Canada and the UK. Neuralink’s ultimate goal is to provide advancements in technology that allow individuals to control devices using their thoughts, with the support of regulatory bodies like the FDA.
