FDA approves Neuralink’s brain chip for second patient

By Stacy Liberatore for Dailymail.com

1:22 PM May 20, 2024, updated 2:15 PM May 20, 2024



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

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

Neuralink revealed this month that some of the 64 wires came loose from the first patient’s brain, causing the chip to malfunction, almost ending the trial that started in January.

A Reuters report quoted “five people familiar with the matter” as saying the issue “has been known for years” through animal testing.

Elon Musk’s Neuralink has been given the green light to implant its brain chip in a second patient after resolving issues that arose during the first human trial
In January, Neuralink implanted a brain chip in its first patient, Noland Arbaugh, who is paralyzed from the shoulders down following a 2016 diving accident

Nolan Arbaugh was the first to get the brain chip after a life-altering driving accident while working as a camp counselor in 2016 left him with “absolutely no feeling” from his shoulders down.

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

However, the company also revealed that some of the wires connected to the chip were retracted weeks after the operation, resulting in a decrease in the number of effective nodes.

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

The US Food and Drug Administration (FDA) on Monday approved the next person and signed off on the company’s planned updates, which include embedding some of the device’s ultra-thin wires more deeply into the brain

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 wires are inserted into the motor cortex of the brain, the area that generates signals to control the body’s movement.

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

Neuralink was able to adjust 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 by thinking alone – a prospect that could help people with spinal cord injuries.

Musk is now looking at June for the implantation of the second patient and aims to have 10 people with the chip this year.

The implant is about the size of a quarter and is equipped with electronics and a battery. The wires are inserted into the motor cortex of the brain, the area that generates signals to control the body’s movement

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

Neuralink also noted that shortly after the surgery, Arbaugh surpassed the world record for the speed at which he could control a cursor with thoughts alone.

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

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

‘It has given me the opportunity to do things on my own again without needing my family day and night.’

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

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

The company did mention that some of the wires attached to the chip had withdrawn from the brain, but the Neuarlink team adjusted the recording algorithm to be more sensitive to signals from neural populations.

Musk first demonstrated the chip in 2020 by demonstrating the technology with a pig named Gertrude
And in 2022, the world saw how a monkey with the implant used his mind to play a video game

This resulted in ‘improving the techniques to translate these signals into cursor movements, and improving the user interface.’

Neuralink said it is now focused on increasing cursor control performance to the same level as that of able-bodied individuals.

“In the future, we plan to extend the Link’s functionality 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.

As she poked around in a pen, viewers saw her brain activity on a large screen.

And in 2022, the world watched as a monkey with the implant used his mind to play a video game.

The device in his brain recorded information about the neurons that fired as he played the game, and learned to predict the moves he would make.

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

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

However, it would still be over a year before the first human trial would begin.

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