Elon Musk-led Neuralink human brain implant trials denied by FDA

Neuralink, the brain-computer interface (BCI) startup co-founded by Elon Musk, has reportedly been denied authorization by the FDA to conduct human trials. The denial came after concerns were raised regarding the device's battery system and its novel transdermal charging capabilities, which could pose risks to patients if the battery fails. 

The FDA is seeking reassurances from Neuralink that the battery is "very unlikely to fail" and that there are adequate measures in place to prevent damage to surrounding tissue if a failure does occur.

Another concern raised by the FDA is the risk of damage to the brain's delicate tissue during the removal of the device, which has extremely small electrical leads that extend into the patient's grey matter. These leads are at risk of breaking off during removal or even during regular use, which could cause them to migrate to other parts of the brain where they might cause damage.

"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.

Despite Musk's confident claims during an open house event last November that Neuralink would secure FDA approval within six months, the prospects of the company bringing a product to market remain distant. Reuters reports that some employees at the company are frustrated by Musk's lack of understanding of the complexity of working with the human brain, with one employee stating that "this is not a car, this is a person's brain."

Neuralink has been working on developing a brain-computer interface that would allow people to control computers or other devices with their thoughts. While the potential applications of such technology are vast, the challenges involved in working with the brain make it a difficult and complex field, and it may be some time before Neuralink is able to bring a product to market.

(With Agency inputs)

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