FDA reportedly denied Neuralink's request to begin human trials of its brain implant

The agency cited 'dozens' of safety issues that must be resolved before moving forward.

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Despite the repeated and audacious claims by its sometimes CEO, Elon Musk, the prospects of brain-computer interface (BCI) startup Neuralink bringing a product to market remain distant, according to a new report from Reuters. The BCI company was apparently denied authorization by the FDA in 2022 to conduct human trials using the same devices that killed all those pigs — namely on account of; pig killing.

"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 questions over whether and how the device can be removed without damaging brain tissue," current and former Neuralink employees told Reuters.

The FDA's concerns regarding the battery system and its novel transdermal charging capabilities revolve around the the device's chances of failure. According to Reuters, 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.

The FDA is also very concerned with potential problems should the device need to be removed wholesale, either for replacement or upgrades, due to the minuscule size of the electrical leads that extend into the patient's grey matter. Those leads are so small and delicate that they are at risk of breaking off during removal (or even during regular use) and then migrating to other parts of the brain where they might get lodged in something important.

During Neuralink's open house last November, Musk's confidently claimed the company would secure FDA approval "within six months," basically by this spring. That estimate is turning out to be as accurate as his guesses for when the Cybertruck might finally enter production. “He can’t appreciate that this is not a car,” one employee told Reuters. “This is a person’s brain. This is not a toy.” Neuralink did not respond to requests for comment.