The Food and Drug Administration (FDA) of the United States rejected the application of Neuralink to begin human trials of its brain chips in development.
Despite repeated claims by its CEO, Elon Musk, the prospects for brain-computer interface (BCI) startup Neuralink bring a product to market remain distant, according to a new report by Reuters.
Delays in testing
According to the report, the FDA denied the company clearance in 2022 for human trials.
“The agency’s main safety concerns involved the device’s lithium battery, the possibility of the implant’s tiny wires migrating to other areas of the brain, and questions about whether and how the device can be removed without damaging brain tissue,” said current and former employees of Neuralink to the medium.
The concerns of the FDA regarding the battery system and its novel transdermal charging capabilities revolve around the potential for device failure.
The FDA is also very concerned about potential problems should the device have to be removed entirely, either for replacement or upgrade, because of the tiny size of the electrical leads that extend into the patient’s gray matter. Those wires are so small and delicate that they run the risk of breaking during removal (or even during regular use) and then migrating to other parts of the brain where they could become lodged in something important.
Still waiting
During the open house of Neuralink last November, Musk confidently asserted that the company would win approval from the FDA “within six months”.
Elon Musk is trying to accelerate the progress of Neuralinka company that wants to implant its first brain chips in humans in the coming months.
On several occasions over the years, Musk has told employees to imagine they have a bomb strapped to their heads in an effort to make them move faster, according to three sources who repeatedly heard the comment. On one occasion a few years ago, Musk told employees that he would cause a “market failure” in Neuralink unless they made further progress, a comment that some employees perceived as a threat to shut down operations.
According to sources, Neuralink launches tests in rapid succession before fixing problems in earlier tests or drawing full conclusions. The result: in general, more animals are tested and killed, in part because the approach leads to repeated testing.
Musk’s insistence is also due to the fact that other companies are already at higher stages than his company. Synchron, for example, has already received FDA approval to perform implants in humans as of last year. Moreover, only 80 sheep have died during its research since 2016.
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