FDA approves Neuralink brain chip for second patient

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By Creative Media News

  • Neuralink gets FDA approval for second brain implant
  • First implant malfunctioned, nearly halting human trials
  • Device helps paralyzed patients control devices via thoughts

Neuralink, which Elon Musk established, has been authorized to implant its brain device in a second patient following the resolution of complications that emerged during the initial human trial.

On Monday, the US Food and Drug Administration (FDA) approved the subsequent individual, thereby approving the company’s proposed modifications, which included the penetration of certain ultrathin wires into the brain.

This month, Neuralink disclosed that the initial patient’s brain experienced a malfunction as a result of the detachment of some of the 64 threads, which nearly terminated the trial that commenced in January.

According to a Reuters report, this issue had been “known about for years” as a result of animal testing, as claimed by “five people familiar with the matter.”

In 2016, Nolan Arbaugh was the first to receive the brain chip after a life-changing driving accident that left him with “absolutely no feeling” from the shoulders down. He was working as a camp counsellor at the time.

Neuralink posted a progress update on Arbaugh on May 8, stating that it had been over 100 days since the device was implanted.

The company also disclosed that the number of effective nodes had decreased as a consequence of the retraction of certain threads connected to the chip in the weeks following the surgery.

According to a report from the Wall Street Journal, the problem was caused by the initial surgery, during which air became trapped inside Arbaugh’s cranium. This condition, pneumocephalus, can result in seizures, brain abscesses, and death if left untreated.

As reported by the Journal, the FDA is permitting Neuralink to proceed with a second patient mere days after the company made applications available. 

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

The strands are inserted into the motor cortex of the brain, which is responsible for generating signals that direct the body’s movement.

According to Arbaugh, 15% of the strands had persisted in his brain following the malfunction, as reported by The Journal. 

Neuralink was able to enhance signal translations without the need to extract the chip by modifying the algorithm.

The company is currently conducting tests on its implant to determine whether it can enable paralyzed patients to operate digital devices through their cognitive processes. This potential benefit could benefit individuals who have sustained spinal cord injuries. 

Musk is now targeting June for the implantation of the second patient and intends to have ten individuals equipped with the device this year. 

According to company blog posts and videos, the device has enabled Arbaugh to play video games, peruse the internet, and move a computer cursor on his laptop by thinking alone.

Neuralink also observed that shortly after the surgery, Arbaugh exceeded the world record for the pace at which he can control a cursor with his thoughts alone.

Within weeks of the surgery, Arbaugh was able to use Link to control his laptop. This enabled him to play computer games with peers, browse the internet, live stream, and use other applications on his MacBook.

“[The Link] has facilitated my reconnection with my family, friends, and the world,” he stated.

“It has enabled me to perform tasks independently once more, without requiring my family’s assistance at all hours of the day and night.”

Arbaugh devotes up to eight hours per day to research, but on weekends, he spends over ten hours engaging in personal activities.

Neuralink reported using the device for 69 hours in a single week, including 35 hours of structured sessions and an additional 34 hours of personal use.

The Neuarlink team modified the recording algorithm to be more sensitive to neural population signals despite the company’s mention that some of the threads affixed to the chip had retracted from the brain.

This led to enhancements in the user interface and improvements in the techniques used to translate these signals into cursor movements.

Neuralink stated that it is currently concentrating on enhancing cursor control performance to the same level as that of non-disabled individuals.

We plan to expand the Link’s functionality to the physical world in the future to facilitate the control of robotic arms, wheelchairs, and other technologies that may enhance the independence of individuals with quadriplegia,” the company stated.

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Musk initially demonstrated the device in 2020 by utilizing a pig named Gertrude to demonstrate the technology.

Viewers observed her cerebral activity on a large screen as she snuffed around in a pen. 

In 2022, the world witnessed a monkey with an implant utilize its consciousness to play a video game.

The device in his brain recorded information about the neurons firing while he played the game, enabling it to forecast the movements he would make. 

Musk declared in November 2022 that Neuralink was anticipated to commence human clinical trials within six months, with vision restoration serving as one of its initial applications.

Musk discussed the potential of neural chip interfaces to facilitate communication and mobility for disabled patients during a ‘Show and Tell’ event on Wednesday.

Nevertheless, the initial human trial would commence for less than a year. 

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