Neuralink knew for years that tiny wires in brain were an issue, Reuters says

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LOS ANGELES - Elon Musk’s Neuralink, known for its ambitious brain-computer interface technology, uses tiny wires to detect and stimulate neural activity. However, according to sources cited by Reuters, the company knew about significant issues with the durability and reliability of these wires for years.

The company reportedly knew from animal testing conducted before its U.S. approval last year that the wires might retract, removing the sensitive electrodes that decode brain signals. Despite this, Neuralink deemed the risk too low to merit a redesign, Reuters reported on Wednesday.

Issues with Neuralink's tiny wires

Neuralink's tiny wires, essential for its brain implants and thinner than human hair, are designed to be implanted in the brain to detect and stimulate neural activity.

However, sources told Reuters that these wires have experienced breakages and malfunctions, posing significant hurdles to the device's long-term functionality and safety. The delicate nature of the wires makes them susceptible to damage, which has been a persistent issue since the company's inception.

Reuters reported that the U.S. Food and Drug Administration was aware of the potential issue with the wires. According to one source, the company had shared the animal testing results, which indicated the risk of the wires retracting, as part of its application to begin human trials.

The FDA declined to confirm its awareness or the significance of the issue, stating it would continue monitoring patient safety in Neuralink's study.

One source noted that if Neuralink continues trials without redesigning the wires, it could face difficulties if more wires retract and algorithm adjustments fail.

Conversely, according to two sources, redesigning the wires poses risks, such as potential brain tissue damage if the wires dislodge or if the device needs to be removed.

Neuralink's first human trial

Neuralink, based in Fremont, California, is among the many groups working on linking the nervous system to computers to help treat brain disorders, overcome brain injuries, and for other applications.

In February, Musk updated on the first human patient with one of the company’s implants, stating during a Spaces event on X that the patient can control a computer mouse with their thoughts: "Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of. Patient is able to move a mouse around the screen by just thinking," Musk said.

In May, Neuralink received approval from the U.S. Food and Drug Administration to proceed with human trials for brain implants. Last fall, the company announced it was seeking volunteers, ideally quadriplegic adults under age 40.

Neuralink displayed on mobile in this multiple exposure photo illustration.

The device, about the size of a large coin, is designed to be implanted in the skull with ultra-thin wires going into the brain. It reads and analyzes brain activity, relaying information wirelessly to a nearby laptop or tablet.

Musk previously posted, "Initial users will be those who have lost the use of their limbs. Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal."

Musk, also CEO of Tesla and SpaceX, launched Neuralink in 2016. While he had sought approval for human trials since 2019, the FDA initially rejected the application in early 2022. ‘

FOX Business contributed to this story.