Musk’s Neuralink has had problems with its tiny wires for years, sources say

Musk’s Neuralink has had problems with its tiny wires for years, sources say

Neuralink’s revelation last week that tiny wires in the brain of its first patient had been pulled out of position is an issue Elon Musk’s company has known about for years, according to five people familiar with the matter.

The company knew from animal tests it had conducted before U.S. approval. last year that the wires might be withdrawn, removing with them sensitive electrodes that decode brain signals, three sources said. Neuralink considers the risk low enough for a redesign to be unwarranted, the source added.

Neuralink 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.

The company said last week that the implant’s tiny wires, which are thinner than a human hair, were withdrawn from a patient’s brain in its first human trial, resulting in fewer electrodes that could measure brain signals.

Signals are translated into actions, such as moving a mouse cursor on a computer screen. The company said it successfully restored the implant’s ability to monitor its patients’ brain signals by making changes including modifying its algorithm to be more sensitive.

The sources declined to be identified, citing a confidentiality agreement they had signed with the company. Neuralink and its executives did not respond to calls and emails seeking comment.

U.S. Food and Drug Administration aware of potential issues with the wire because the company shared the results of animal tests as part of its application to begin human trials, one of the people said.

The FDA declined to comment on whether it was aware of the issue or its possible significance. The agency told Reuters it would continue to monitor the safety of patients enrolled in the Neuralink study.

If Neuralink continues the experiment without a redesign, it could face challenges if more wires come undone and its tweaks to the algorithm prove insufficient, one of the sources said.

But thread redesign comes with its own risks. Anchoring it in the brain, for example, could result in damage to brain tissue if the threads dislodge or if the company has to remove the device, two sources said.

The company has worked to design the thread in a way that makes removal seamless, so the implant can be updated over time as technology improves, current and former employees said.

In January, Neuralink implanted the device in the brain of its first patient, Noland Arbaugh, who was paralyzed from the shoulders down as a result of a diving accident in 2016.

In the weeks following surgery, “a number of threads are pulled back from the brain,” Neuralink said in a blog update last week. The release made no mention of the adverse health effects on Arbaugh and did not disclose how many of the 64 device threads were pulled or stopped collecting brain data.

So far, the device has allowed Arbaugh to play video games, surf the Internet and move the computer cursor on his laptop by thinking alone, according to a company blog post and video. Neuralink says that shortly after the surgery, Arbaugh broke the world record for the speed at which he could control a cursor with just thought.

It is common for medical device companies to resolve different design problems during animal testing and issues that arise during animal and clinical testing, according to researchers and outside sources who have worked at Neuralink and other medical device companies.

Experts who have studied brain implants say the issue of thread movement can be difficult to resolve, in part due to the mechanism of how the brain moves inside the skull.

Robert Gaunt, a neuroengineer at the University of Pittsburgh, described the movement of the wire immediately after surgery as disappointing but said it was unexpected. “In the days, weeks, months after an implant like this, it’s probably the most vulnerable time,” he said.

The pig is giggling

In 2022, the FDA initially rejected Neuralink’s application to begin human trials, raising safety concerns about the thread, Reuters exclusively reported last year.

Neuralink is conducting additional animal testing to address those concerns, and the FDA last year granted the company approval to begin human trials.

The company found that a subset of pigs implanted with its device developed a type of inflammation in the brain called granuloma, raising concerns among Neuralink researchers that the thread could be to blame, according to three sources familiar with the matter and records seen by Reuters.

A granuloma is an inflammatory tissue reaction that can form around a foreign object or infection.

In at least one case, a pig developed a severe case. Company records reviewed by Reuters showed that the pig developed a fever and shivering after the operation. Neuralink researchers didn’t recognize the extent of the problem until they examined postmortems of pig brains.

Inside Neuralink, researchers debated how to fix the issue and began a months-long investigation, sources familiar with the matter said.

In the end, the company was unable to determine the cause of the granuloma, but concluded that the device and attached thread were not to blame, one of the sources said.

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