The Food and Drug Administration is expected to allow Elon Musk’s brain chip company Neuralink to implant its device in a second patient as early as next month, according to reports.
The federal agency appears satisfied with Neuralink’s proposal to correct an error reported in Neuralink’s first patient, 30-year-old Noland Arbaugh. Noland Arbaugh is a 30-year-old quadriplegic who has managed to not only think but also control a cursor on a computer screen. He plays games and communicates with friends.
News of FDA approval was first The Wall Street Journal reported on monday.
Earlier this month, Neuralink revealed that the implant’s tiny wires, which are thinner than a human hair, had receded from Arbor’s brain, resulting in fewer electrodes that could measure brain signals.
According to the magazine, Neuralink learned that Arbaugh’s brain moved up to three times more than the company expected, which caused the wire to retract.
Reuters reported last week that animal studies conducted by the company ahead of its U.S. approval last year showed that when the wires retracted, sensitive electrodes that decipher brain signals could also be removed. He said he knew.
The report said Neuralink determined the risks were low enough not to warrant a redesign.
The signals are translated into actions, such as moving a mouse cursor on a computer screen.
The company said it was able to restore the implant’s ability to monitor patients’ brain signals by making changes such as making the algorithm more sensitive.
Arbaugh lost movement from the shoulders down in a 2016 driving accident and had a chip about the size of a quarter placed in his brain in January.
The chip contains a battery and 64 outer threads thinner than a human hair that attach to the brain’s motor cortex to relay neural signals.
But after a few weeks, the company says, “numerous strands retracted from the brain.”
“I was so high and then I was so low. It was very, very difficult,” Arbaugh told the newspaper about his reaction to having part of his abilities taken away. .
“I cried.”
The magazine said Neuralink told Arbaugh that 15% of the threads in his brain remained intact and that the company had tweaked the software to regain much of the device’s functionality.
The company told the FDA it plans to resolve the accident that affected Mr. Arbaugh by inserting an implant deep into the brain’s motor cortex.
In Arbaugh’s case, the implant was placed 3 to 5 millimeters deep into the motor cortex of his brain.
The FDA agreed to Neuralink’s proposal to place the implant 8 millimeters into the motor cortex in future patients.
According to Reuters, the FDA was aware of the potential problems with the wire because the company shared animal test results as part of its application to begin human trials.
The magazine says more than 1,000 quadriplegic patients have signed up to register in hopes of becoming the second person to receive a brain implant.
Neuralink plans to narrow the list to less than 100 candidates. The company plans to make a final decision on patients within the next month, the publication said.
Last week, Musk announced on his social media platform X that Neuralink was still accepting applications.
Neuralink’s goal is to implant the technology in 10 people by the end of the year. The magazine said the company aims to attract a diverse patient base, but so far the overwhelming majority of applicants who have signed patient registries have been white men.
Neuralink is also seeking regulatory approval from authorities in Canada and the United Kingdom.
