Despite repeated daring claims from CEO Elon Musk, the prospect of brain-computer interface (BCI) startup Neuralink coming to market remains remote. The company’s permission to conduct human trials using devices that cause the death of pigs has apparently been denied by the FDA.
“The FDA’s primary safety concerns were related to the device’s lithium battery, the potential for the implant’s tiny wires to cross into other parts of the brain, and whether and how the device can be removed without damaging brain tissue,” said current and former Neuralink employees.
FDA’s concerns about the battery system and new transdermal charging features center around the possibility of device malfunction. The agency seeks assurance that the battery is unlikely to fail because if it does, a discharge of electrical current or heat energy from a torn package could fry the surrounding tissue.
The FDA also has concerns about the operation if the device needs to be removed for repair or updating. Because this device works depending on the gray matter of the brain. Because the electrodes are very small and sensitive, there is a potential for them to break during removal and remain in the brain.
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