Exclusive: Musk’s Neuralink has faced issues with its tiny wires for years, sources say
The latest news from Neuralink is that the small wires in the first patient’s brain implant had moved out of position, the problem the company has been aware of for years, as four sources revealed it to be.
The animal tests carried out before winning the U. S. approval last year showed that the wires might retract, removing the electrodes that decode the brain signals. Although the company acknowledged the danger, it decided that the danger was not high enough to abandon a redesign, as three sources have stated.
Neuralink is in the phase of developing its implant that will allow paralyzed people to use digital devices only through their thoughts, which could be helpful for those with spinal cord injuries. Last week, the company disclosed the fact that during its first human trial, the very thin wires, which are thinner than a human hair, shrunk from the brain of the patient and thus the number of functional electrodes was reduced.
These electrodes are responsible for changing the brain signals into actions, for example, moving the computer cursor. Neuralink said it was able to bring the implant back to life by making the algorithm more delicate.
The sources, who were forced to remain anonymous because of the confidentiality agreements, said that Neuralink and its executives did not reply to the requests for comments. The U. S. Food and Drug Administration (FDA) knew about the wire retraction problem, as it had reviewed the animal testing results that were in the Neuralink human trial application, and that was the case according to one source. The FDA did not comment on its concern about the problem or the significance of the issue but it said that it would go on with monitoring the patient safety in Neuralink’s study.
The trials of the next phases will be continued without the redesign which in turn can be one of the causes of the problems if more than one wires are retracted and the tweak of the algorithm turns out to be insufficient, as per one of the sources. Still, on the other hand, the new design would mean the risk of brain tissue damage in case the thread breaks or the device is removed, as per two sources.
The artisans of Neuralink intend to design the spears for smooth removal, thus, enabling the future upgrades of the technologies of today and yesterday, the employees of the same company said.
In January, Neuralink fitted its device in the brain of Noland Arbaugh, who is paralyzed from the shoulders down from a 2016 diving accident. Several days after the surgery, the threads retracted from the brain and Neuralink reported it last week. No one from the company talked about the medical problems related to the 64 threads or was it the case that all the 64 threads were affected.
Nonetheless, the device has let Arbaugh to play video games, surf the internet, and move a cursor on his laptop through thinking alone. According to the research, Arbaugh, the first person to achieve the world record for cursor control speed using only his thoughts, was able to surpass the world record in no time during the experiment by Neuralink.
Medical device companies usually face design issues during animal trials, and even then, problems occur during both animal and clinical trials as well, according to external researchers and sources with experience at Neuralink and other medical device companies. Brain implant specialists, in fact, admit that the thread movement is a complicated problem since the brain moves within the skull.
Robert Gaunt, a neural engineer at the University of Pittsburgh, said that the wire retraction after the surgery was not a surprise but a disappointing event. “The days, weeks, and months following the implant, which are possibly the most sensitive time, are the best time to be careful, this is what he said.
Pig Testing Concerns
In 2022, the FDA first denied Neuralink’s application for human trials, because of the safety risks related to the threads, which were the FDA’s reasons. Neuralink conducted more animal testing and therefore, the FDA authorized them to conduct human trials last year.
The mentioned tests, some pigs had brain inflammation known as granulomas, which caused the researchers at Neuralink to be worried about the threads, due to three sources and documents that Reuters reviewed. Granulomas can be present around the foreign bodies or infections.
In a extreme case, a pig had a fever and respiratory problems after surgery. The real magnitude of the problem was only realized during the autopsy. The internal debates of Neuralink and the long investigation which was for months could not find the reason of the granulomas, but Neuralink decided that the device and threads were not the culprit one source said.
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