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

The agency cited "dozens" of security issues that need to be resolved before moving forward.

Despite repeated and bold claims by its sometimes CEO, Elon Musk, brain-computer interface (BCI) startup Neuralink's prospects of bringing a product to market remain remote, according to a new report from Reuters.< /em>The BCI company was apparently denied FDA clearance in 2022 to conduct human trials using the same devices that killed all those pigs — notably due to; slaughter of pigs.

"The agency's main safety concerns involved the device's lithium battery; the possibility that the implant's tiny wires could migrate to other areas of the brain; and questions about whether and how the device can be removed without damaging brain tissue," former Neuralink employees told Reuters.

FDA concerns about the battery system and its new transdermal charging capabilities revolve around the risk of device failure. According to Reuters, the agency seeks to ensure that the battery is "very unlikely to fail" because if it did, the discharge of electrical current or thermal energy of a ruptured pack could fry the surrounding tissues.

The FDA is also very concerned about potential issues if the device has to be removed en masse, whether for replacement or upgrade, due to the tiny size of the electrical wires that extend into the gray matter of the patient. These leads are so small and delicate that they are at risk of breaking upon removal (or even with regular use) and then migrating to other parts of the brain where they could lodge in something important.

At Neuralink's open house last November, Musk confidently asserted that the company would gain FDA approval "within six months," essentially by this spring. This estimate turns out to be as accurate as his guesses as to when the Cybertruck might finally enter production. "He can't understand it's not a car," an employee told Reuters. "It's a person's brain. It's not a toy." Neuralink did not respond to requests for comment.

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