Neuralink has approached one of the US’ biggest neurosurgery centres to be a clinical trial partner as it gears up to test its devices on humans following a push for regulators approval.
Barrow Neurological Institute, an Arizona-based neurological disease treatment and research organisation, has been revealed to be the centre Elon Musk’s company asked to help carry out the human trials. Other centres, which are not named, are also in talks with the company as a trial partner.
The organisation has previously helped standardise brain implant surgeries in which the patient can remain asleep, although the devices they’ve been implanting works with deep brain stimulation devices, different than Neuralink’s brain computer interface (BCI) device.
This standardisation lends to Musk’s vision for Neuralink’s brain chip to become as ubiquitous as laser eye surgery. Neuralink has been developing its BCI implants since 2016, which it hopes will eventually be a cure for brain-related conditions such as paralysis and blindness. The devices uses electrodes that penetrate the brain or sit on its surface to provide direct communication to computers and even, as Musk has posited, AI tools. Musk said in November that Neuralink was aiming to get underway with human trials in six months.
Yet the newest milestone follows off a 2022 setback from the US Food and Drug Administration after it rejected the company’s first application to progress to human trials over ‘major safety concerns’. Neuralink has since reportedly been working to address the agency’s concerns, but no company has yet received approval to bring a BCI implant to the market although competitor Synchron claim to have put the first BCI device in a human in the US in 2022 following FDA approval the year before.
The concerns include 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.
Neuralink’s is also facing two federal probes into the company’s practices: one from the Department of Agriculture over potential animal-welfare violations in 2022 and the Department of Transportation over potential mishandling of hazardous pathogens during the company’s partnership on animal trials with University of California, Davis between 2018 and 2020, a partnership the university ended for undisclosed reasons in 2020. The company has reportedly overseen the death of around 1,500 animals following experiments since 2018.
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