Elon Musk gets approval from FDA to implant his Neuralink brain chip into a second patient
Elon Musk’s Neuralink has been given a green light to implant its brain chip in a second patient after fixing issues that struck during the first human trial.
The US Food and Drug Administration (FDA) approved the next person on Monday, signing off on the company’s planned updates that included embedding some of the device’s ultrathin wires deeper into the brain.
Neuralink revealed this month that some of 64 threads detached from the first patient’s brain, causing the chip to malfunction - nearly ending the trial that began in January.
A report by Reuters cited 'five people familiar with the matter' had claimed that this issue had been 'known about for years' from animal testing.
Elon Musk’s Neuralink has been given a green light to implant its brain chip in a second patient after fixing issues that struck 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 due to a 2016 diving accident
Nolan Arbaugh was the first to receive the brain chip following a life-changing driving accident whilst working as a camp counselor in 2016, which left him with 'absolutely no feeling' from the shoulders down.
Neuralink shared a progress update about 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 threads connected to the chip had retracted weeks after the surgery, resulting in a decrease in the number of effective nodes.
A report from the Wall Street Journal claimed that the issue stemmed from the initial surgery when air became trapped inside Arbaugh's skull, which is known as pneumocephalus that can cause seizures, brain abscess and death if untreated.
The US Food and Drug Administration ( FDA ) approved the next person on Monday, signing off on the company’s planned updates that included embedding some of the device’s ultrathin wires deeper 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 had opened up applications.
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The implant is about the size of a quarter, which is fitted with electronics and a battery.
The threads are inserted into the brain's motor cortex, the region that generates signals to direct the movement of the body.
Arbaugh told The Journal that 15 percent of the threads had remained in his brain after the malfunction.
Neuralink was able to modify the algorithm to boost 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 eyeing June for 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, which is fitted with electronics and a battery. The threads are inserted into the brain's motor cortex, the region that generates signals to direct the movement of the body
So far, the device has allowed Arbaugh to play video games, browse the internet and move a computer cursor on his laptop by thinking alone, according to company blog posts and videos.
Neuralink also noted that soon after the surgery, Arbaugh surpassed the world record for the speed at which he can control a cursor with thoughts alone.
In just weeks after the surgery, Arbaugh was able to control his laptop using Link, which he did to play computer games with friends, , browse the internet, live stream and use other applications on his MacBook.
'[The Link] has helped me reconnect with the world, my friends, and my family,' he said.
'It's given me the ability to do things on my own again without needing my family at all hours of the day and night.'
Arbaugh spends the up to eight hours a day contributing to research, but spends more than 10 hours a day on weekends doing personal activities.
Neuralink said that he recently used the device for a total of 69 hours in a single week - 35 hours of structured sessions and an additional 34 hours of personal use.
The company did mentioned that some of the threads attached to the chip had retracted from the brain, but the Neuarlink team modified the recording algorithm to be more sensitive to neural population signals.
Musk first demonstrated the chip in 2020 by demonstrating the technology with a pig named Gertrude
And in 2022, the world watched a monkey with the implant use its mind to play a video game
This resulted in 'improved the techniques to translate these signals into cursor movements, and enhanced the user interface.'
Neuralink said that it is now focusing on increasing cursor control performance to the same level as that of able-bodied individuals.
'In the future we intend to extend the Link's functionality to the physical world to enable control of robotic arms, wheelchairs, and other technologies that may help increase independence for people living with quadriplegia,' the company said
Musk first demonstrated the chip in 2020 by demonstrating the technology with a pig named Gertrude.
While she snuffed around in a pen, viewers saw her brain activity on a large screen.
And in 2022, the world watched a monkey with the implant use its mind to play a video game.
The device in his brain recorded information about the neurons firing while he played the game, learning to predict the movements 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 is restoring vision.
Musk held a 'Show and Tell' event on Wednesday where he spoke about how the brain chip interfaces could enable disabled patients to move and communicate again.
However, it would be more than one year until the first human trial began.