Neuralink Corp’s malfunctioning of tiny wires in the brain implant has been known for years, even before the company acknowledged it in a blog last week.
The problem was first identified during animal testing conducted prior to the company’s approval for human trials last year, but the risk was deemed insufficient to require a redesign, according to a report from Reuters.
Neuralink aims to enable paralyzed individuals to control digital devices with their thoughts through its brain implant technology.
The company, founded by Elon Musk, recently disclosed that the implant’s ultra-thin wires, finer than human hair, had retracted from the brain of their first human subject during the initial trial, affecting the number of electrodes able to read brain signals.
Despite this setback, the company adjusted its algorithm to regain the implant’s ability to monitor brain activity.
The U.S. Food and Drug Administration (FDA) was aware of this potential issue, as it had been reported in the animal testing results submitted by Neuralink during their application for human trials.
However, the FDA has not commented on the specifics or the significance of the issue. The agency has assured that it will continue to oversee the safety of patients in Neuralink’s study.
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Continuing trials without redesigning the wires might pose challenges if more wires retract and the algorithm modifications prove inadequate.
Redesigning the wires comes with its own risks, including potential damage to brain tissue during removal or if the wires dislodge.
Neuralink’s design aims to allow seamless removal and updates of the implant as technology advances.
In January, Neuralink implanted its device in Noland Arbaugh, who was paralyzed from a diving accident in 2016.
The company reported in a recent blog post that several wires retracted from his brain following the surgery. There were no mentions of health issues for Arbaugh or details on the exact number of wires that malfunctioned.
The implant has enabled Arbaugh to engage in activities like playing video games and browsing the Internet solely through thought.
Initially, the FDA had rejected Neuralink’s application for human trials in 2022 due to safety concerns, particularly regarding the wires.
Further animal testing was conducted to address these issues, leading to eventual approval. Some pigs tested with the device developed brain inflammation called granulomas, which raised internal debates and investigations at Neuralink.
The company concluded that the device and threads were not responsible for the inflammation.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo via Wikimedia Commons
