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Despite repeated bold claims from occasional CEO Elon Musk, the prospects for Brain-Computer Interface (BCI) startup Neuralink to bring a product to market remain distant. Reuters. BCI was apparently denied permission by the FDA to conduct human trials in 2022 using the same device that killed all those pigs. pig killer.
“The agency’s main safety concerns include the device’s lithium battery, the potential for the implant’s tiny wires to travel to other areas of the brain, and whether the device can be removed without damaging brain tissue. , and questions about how it could be removed.” Reuters.
FDA concerns about battery systems and their new transdermal charging capabilities relate to the potential for device failure.according to Reuters.
The FDA is also very concerned about the potential problems if the device needs to be removed extensively for replacement or upgrade due to the very small size of the electrical leads that extend into the gray matter of patients. These leads are so small and delicate that they can break during removal (or even during normal use) and travel to other parts of your brain where they can get caught on something important.
At Neuralink’s open house last November, Musk confidently claimed that the company would have FDA approval “within six months” by this spring. That estimate turned out to be as accurate as his guess as to when the Cybertruck will finally enter production. “He can’t understand that this isn’t a car,” said one employee. Reuters“This is a human brain. This is not a toy.” Neuralink did not respond to a request for comment.
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