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Neuralink Faces Setbacks with Brain Implant Wires in Human Trials Despite FDA Approval

Neuralink has been aware of wire retraction issues for years, according to insider sources. The company deemed the risk low enough to proceed without a redesign. Modifications were made to restore the implant's ability to monitor brain signals.

Neuralink, the brain-computer interface company founded by Elon Musk, has been grappling with problems related to its tiny wires for several years, according to insider sources. The recent disclosure that the wires inside the brain of its first patient had pulled out of position was a known issue within the company.


During animal testing conducted prior to receiving U.S. approval last year, Neuralink discovered that the wires had the potential to retract, taking with them the crucial electrodes responsible for decoding brain signals. Despite this knowledge, the company deemed the risk to be low enough to proceed without a redesign.


Neuralink's implant aims to provide paralysed patients with the ability to control digital devices using their thoughts alone, offering hope to individuals with spinal cord injuries. However, in the first human trial, the implant's thin wires, thinner than a human hair, retracted from the patient's brain, resulting in a reduced number of electrodes capable of measuring brain signals.


To address this setback, Neuralink made modifications, including adjusting the algorithm to enhance sensitivity, thereby restoring the implant's ability to monitor the patient's brain signals. The sources, who spoke on condition of anonymity due to confidentiality agreements, revealed that the U.S. Food and Drug Administration (FDA) was aware of the wire issue based on the animal testing results shared by Neuralink during the application process for human trials.


While the FDA declined to comment on the significance of the issue, it assured that patient safety would continue to be monitored throughout Neuralink's study. However, if the trials proceed without a redesign and more wires pull out, the company could face challenges if the algorithm adjustment proves insufficient.


Redesigning the wires poses its own risks, such as potential brain tissue damage if the threads dislodge or if the device needs to be removed. Neuralink has been working on designing the threads to allow for seamless removal, enabling future updates as technology advances.


In January, Neuralink successfully implanted the device in the brain of its first patient, Noland Arbaugh, who is paralysed from the shoulders down due to a diving accident in 2016. Following the surgery, some threads retracted from the brain, but no adverse health effects were reported. Arbaugh has been able to play video games, browse the internet, and control a computer cursor on his laptop using his thoughts alone.


Experts in the field of brain implants acknowledge that issues with thread movement can be challenging to solve, given the mechanics of how the brain moves within the skull. Despite the setback, researchers remain optimistic, recognising that the immediate post-implantation period is the most vulnerable.


Neuralink's journey has not been without obstacles. In 2022, the FDA initially rejected the company's application for human trials, citing safety concerns related to the threads. Neuralink conducted additional animal testing to address these concerns, and the FDA eventually granted approval for human testing.


During the animal testing phase, some pigs implanted with Neuralink's device developed a type of brain inflammation called granulomas, raising concerns about the threads' potential role. However, after an extensive investigation, the company concluded that the device and threads were not responsible for the condition.

 
  • Neuralink has been aware of wire retraction issues for years, according to insider sources.

  • The company deemed the risk low enough to proceed without a redesign.

  • Modifications were made to restore the implant's ability to monitor brain signals.


Source: REUTERS

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