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FDA green-lights human trials of brain implant technology

Posted on the 31st May 2023

Brain implant

The US Food and Drug Administration (FDA) has approved an application by Neuralink, Elon Musk’s brain-implant company, to begin in-human clinical studies.

Musk has ambitious plans for the company and envisions both disabled and healthy individuals swiftly getting surgical implants at local centres. He is optimistic that devices will eventually be able to cure a range of conditions, including obesity, autism, depression, and schizophrenia, as well as enabling web browsing and telepathy.

The South African billionaire has said he is so confident in the device’s safety that he would be willing to implant them in his children.

However, as recently as March of this year, the FDA rejected Neuralink’s application to begin human trials following reports by Reuters that more than 1,500 animals had been killed in the development of the Neuralink Link brain-computer interface (BCI) since 2018.

An investigation by the US Department of Agriculture's (USDA) Inspector General is ongoing into these allegations.

The FDA had raised additional concerns regarding the lithium battery used by the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.

Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation to neural prosthetic controls and the capacity "to rewind memories or download them into robots," Musk promised in 2020.

BCIs translate the analog electrical impulses of the brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1s and 0s that computers understand.

Since the BCI needs to be surgically installed in a patient's brain, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving its approval for commercial use.

While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers.

Related: Pioneering trial targets brain tumors

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