FDA approves Neuralink brain chip for second patient

Elon Musk’s Neuralink has been given the green light to implant its brain chip in a second patient after fixing problems encountered in its first human trial.

The U.S. Food and Drug Administration (FDA) approved the next person on Monday, approving the company’s planned updates that include embedding some of the device’s ultra-thin wires deeper into the brain.

Neuralink revealed this month that some of the 64 threads detached from the first patient’s brain, causing the chip to malfunction – nearly ending the trial that began in January.

A Reuters report quoted that “five people familiar with the matter” claimed that this animal testing problem “has been known about for years.”

Nolan Arbaugh was the first to receive the brain chip after suffering a life-changing car accident while working as a camp counselor in 2016 that left him “absolutely numb” from the shoulders down.

Neuralink shared a progress update on Arbaugh on May 8, saying it had been more than 100 days since the device was implanted.

However, the company also revealed that some of the threads connected to the chip had retreated weeks after surgery, leading to a reduction in the number of effective knots.

A Wall Street Journal report claimed that the problem stemmed from the initial surgery, which trapped air in Arbaugh’s skull, a condition known as pneumocephalus, which if left untreated can lead to seizures, brain abscesses and death.

The Journal also reported that the FDA is allowing Neuralink to move forward with a second patient, which comes days after the company opened applications.

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The implant is about the size of a quarter and is equipped with electronics and a battery.

The threads are inserted into the brain’s motor cortex, the region that generates signals to control the body’s movement.

Arbaugh told The Journal that 15 percent of the threads remained in his brain after the malfunction.

Neuralink was able to modify the algorithm to improve signal translations without having to remove the chip.

The company is testing its implant to give paralyzed patients the ability to use digital devices just by thinking – a prospect that could help people with spinal cord injuries.

Musk is now aiming to implant the second patient in June and aims to have 10 people with the chip this year.

According to blog posts and videos from the company, the device has so far allowed Arbaugh to play video games, surf the Internet and move a computer cursor on his laptop by thinking alone.

Neuralink also found that shortly after the surgery, Arbaugh beat the world record for the speed at which he can control a cursor using just his mind.

Just weeks after surgery, Arbaugh was able to control his laptop via Link to play computer games with friends, surf the Internet, live stream and use other applications on his MacBook.

‘[The Link] “Help me reconnect with the world, my friends and my family,” he said.

“It gave me the opportunity to do things on my own again without having to rely on my family 24/7.”

Arbaugh spends up to eight hours a day participating in research, but spends more than ten hours a day on weekends engaged in personal activities.

Neuralink said he recently used the device for a total of 69 hours in a single week – 35 hours of structured sessions and another 34 hours of personal use.

While the company mentioned that some of the threads attached to the chip had withdrawn from the brain, the Neuarlink team modified the recording algorithm to be more sensitive to signals from the neural population.

This resulted in “improving the techniques for translating these signals into cursor movements and improving the user interface.”

Neuralink explained that it is currently focused on increasing cursor control performance to the same level as physically healthy people.

“In the future, we intend to extend the functionality of the Link into the physical world to enable control of robotic arms, wheelchairs and other technologies that can help increase the independence of people with quadriplegia,” the company said

Musk first demonstrated the chip in 2020 by demonstrating the technology with a pig named Gertrude.

While she sniffed around in a pen, viewers could see her brain activity on a large screen.

And in 2022, the world saw a monkey with the implant use his mind to play a video game.

The device in his brain recorded information about the neurons that fired during the game, learning to predict the movements he would make.

In November 2022, Musk announced that Neuralink is expected to begin human clinical trials in six months, and one of its first targeted applications will be restoring vision.

Musk hosted a “Show and Tell” event on Wednesday where he talked about how brain chip interfaces could enable disabled patients to move and communicate again.

However, it would be more than a year before the first human trials began.