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Neuralink receives FDA clearance to begin human trials of its brain-computer interface

Engadget

Turns out Elon Musk's FDA prediction was only off by about a month. After reportedly denying the company's overtures in March, the FDA approved Neuralink's application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday. 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, to the capacity "to rewind memories or download them into robots," Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1's and 0's that computers understand. Since that BCI needs to be surgically installed in a patient's noggin, the FDA -- which regulates such technologies -- requires that companies conduct rigorous safety testing before giving its approval for commercial use.


The Morning After: FDA reportedly denied Neuralink's request to begin human trials of its brain implant

Engadget

Neuralink's efforts to bring a brain-computer interface still have a way to go. According to a new report from Reuters, Elon Musk's startup was apparently denied authorization by the FDA in 2022 to conduct human trials using the same devices that, well, killed 1,500 animals. Those tests, according to internal reports, lead to needless suffering and death of test subjects. 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." The FDA is concerned that, because of the minuscule size of the electrical leads, they are at risk of breaking off during removal (or even during use). At Neuralink's open house last November, Musk claimed the company would secure FDA approval "within six months," basically by this spring.


FDA reportedly denied Neuralink's request to begin human trials of its brain implant

Engadget

Despite the repeated and audacious claims by its sometimes CEO, Elon Musk, the prospects of brain-computer interface (BCI) startup Neuralink bringing a product to market remain distant, according to a new report from Reuters. The BCI company was apparently denied authorization by the FDA in 2022 to conduct human trials using the same devices that killed all those pigs -- namely on account of; pig killing. "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," current and former Neuralink employees told Reuters. The FDA's concerns regarding the battery system and its novel transdermal charging capabilities revolve around the the device's chances of failure. According to Reuters, the agency is seeking reassurances that the battery is "very unlikely to fail" because should it do so, the discharge of electrical current or heat energy from a ruptured pack could fry the surrounding tissue.


Elon Musk's brain chip company Neuralink to begin human trials!

#artificialintelligence

Elon Musk-run brain-machine interface company Neuralink is preparing to launch clinical trials that will implant brain chips in humans. Elon Musk's brain-interface technology company Neuralink may start implanting microchips in human beings from 2022. Neuralink is preparing to launch clinical trials that will implant brain chips in humans. Cofounded by Elon Musk in 2016, Neuralink is working on a chip that would be implanted in our brains to record and stimulate brain activity. This chip is being created for medical applications such as treating serious spinal cord injuries and neurological disorders.