FDA reportedly denied Neuralink's request to begin human trials of its brain implant
Despite the repeated and audacious claims by its sometimes CEO, Elon Musk, the prospects of brain-computer interface startup Neuralink bringing a product to market remain distant, according to a new report fromThe BCI company was apparently denied authorization by the FDA in 2022 to conduct human trials using the same devices"The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and...
device can be removed without damaging brain tissue," current and former Neuralink employees toldThe FDA's concerns regarding the battery system and its novel transdermal charging capabilities revolve around the the device's chances of failure. According to, the agency is seeking reassurances that the battery is"very unlikely to fail" because should it do so, the discharge of electrical current or heat energy from a ruptured pack could fry the surrounding tissue.
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