Elon Musk‘s Neuralink has apparently been denied human trials for its brain implants by the FDA. The company has been working in the field of brain computer interface but was denied the trials back in 2022. So here are all the details.
According to a new report, former and current employees of the startup have revealed that “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.” The FDA has expressed concerns regarding the battery system and its novel transdermal charging capabilities.
The issue is related to the device’s chance of failing after being implanted. The new report added that the agency is looking for reassurances that the battery is “very unlikely to fail”. In other words, the FDA would only approve of the trials once Neuralink proves safety of the implant since the discharge of electrical current or heat energy from a ruptured pack can possibly lead to burning of the surrounding tissue.
The FDA also stated that there were potential risks if the device would be needed to be removed for upgrades or replacements since the small size of the electrical leads that extend into the patient’s brain. One Starlink employee stated that “He can’t appreciate that this is not a car. This is a person’s brain. This is not a toy.”
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