FDA reportedly rejects Neuralink to begin human trials of brain implant

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Although CEO Elon Musk is behind the scenes, Neuralink’s “brain-computer interface” technology does not seem to be closer to realization.Archyde.com reportsIn 2022, the US Food and Drug Administration (FDA) rejected Neuralink’s application to start human trials. The FDA’s main concerns, according to information gathered by Archyde.com from current and former employees, are the safety of the built-in lithium battery, whether the tiny wires inside can travel elsewhere in the brain, and how the device can survive without damaging the brain. Three facets are removed from the premise of the organization.

When it comes to batteries, the FDA is concerned regarding the risk of spontaneous combustion, or even a short circuit, often associated with lithium batteries. Whether it is high heat or instantaneous current emitted by both, it may cause great damage to the surrounding tissues of the brain. In addition, Neuralink’s device is charged wirelessly, and the safety of this part for the brain has yet to be verified. There is also the question of what to do with the tiny wires extending from the brain implant should it be removed or upgraded. There is a great risk that these wires will break in the brain when they are removed (or even in normal use), and if they slowly drift to other parts of the brain, even the life-controlling center, they will also be damaged. There will be danger.

In December last year, Musk stated at Neuralink’s third show & tell sharing session that Neuralink would obtain FDA approval within six months, but obviously the situation is not that simple. “He (Musk) can’t understand that this is not a car. This is a human brain, not a toy,” an employee told Archyde.com. Neuralink did not respond to requests for comment.

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