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.
Source: Google
The FDA also raises concern about the potential for harm to the delicate tissue of the brain during the removal of the device, which includes incredibly tiny electrical wires that reach into the patient’s gray matter. These leads run the danger of breaking off during removal or even normal use, which could send them straying into other parts of the brain where they could cause harm.
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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,”
Source: Google
Although Elon Musk’s assurance that Neuralink would obtain FDA approval within six months during a November open house event, Reuters claims that the business has little prospect of bringing a product to market anytime soon. One employee at Neuralink reportedly expressed displeasure with Elon Musk’s understanding of the challenges of working with the human brain, saying that “this is not a car, this is a person’s brain.”
The brain-computer interface being developed by Neuralink will allow users to control computers and other electronic devices with their thoughts. Although the enormous potential of this technology, working with the brain faces numerous difficulties that make this field complex and challenging. Due to the difficulty, Neuralink might take some time to release a product on the market.