FDA denied Elon Musk’s Neuralink human brain implant trials

Neuralink, a brain-computer interface company co-founded by Elon Musk, requested FDA approval to begin human trials for its product. Concerns about the battery system of the device and its distinctive transdermal charging feature, which could provide potential risks to patients in the case of battery failure, led to the FDA's decision.

The FDA is asking Neuralink to validate that their battery is "very unlikely to fail" and to show that all safety measures are in place to protect the surrounding tissue in the event of a failure.

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The device's removal might potentially harm the brain's fragile structure since its minuscule electrical wires extend into the patient's gray matter, according to the FDA. During removal or even normal use, these leads run the danger of breaking off, which might send them migrating to other parts of the brain where they could harm tissue.

What Current and former Neuralink employees told Reuters

"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,"