Neuralink is said to have known about problems with chip threads
Stitches came loose in the first patient with a Neuralink brain chip. The company is said to have been aware of the problem – as was the regulatory authority.
According to a Reuters report, Neuralink knew about the difficulties of loosening sutures even before the brain chip was used in humans.
(Image: Shutterstock/Wit Olszewski)
Elon Musk's medical technology company Neuralink admitted last week that the wires of its brain chip had come loose in the wearer's head. According to research by the Reuters news agency, the company had been aware of this problem for years.
The chip is designed to enable paralyzed people to operate digital devices with their thoughts. The first patient can use the brain-computer interface (BCI) to play Mario Kart, for example, and control a kind of mouse with his thoughts.
The problem has already occurred in animal experiments
Reuters refers to the statements of five unnamed "people familiar with the matter". According to them, the wires had already come out of position in animal tests that Neuralink had carried out prior to US approval- and with them the sensitive electrodes that decode the brain signals. "Neuralink assessed the risk to be so low that it was not worth redesigning," the report continues. The company did not respond to an inquiry from Reuters.
The U. S. Food and Drug Administration (FDA) was also aware of this potential problem, Reuters writes, citing internal sources. The agency would have had the information on the animal experiments when Neuralink applied for permission to test the chip on humans. The authority did not want to comment on this either, but stated that it would monitor the safety of participating patients.
Redesign involves risks
Both the continuation of the studies without any changes and the redesign would involve risks: If more wires failed or if the change to the algorithm was not sufficient, this would pose problems for the company. At the same time, a redesign is risky, as the threads have to be anchored in the sensitive brain tissue. If Neuralink has to remove the device at some point, the tissue could suffer. However, according to the report, the problem of loosening threads is difficult to solve.
In 2022, the application for approval for human trials failed. At the time, the FDA saw too many risks.
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