BOMBSHELL: FDA Denied Elon Musk’s Neuralink Human Trials in 2022
Musk’s public optimism may be a screen…
Elon Musk, the eccentric billionaire whose recent acquisition of Twitter has been at the forefront of his public image, has long seen himself as an innovator. Twitter’s steep learning curve may not be providing us with an example of Musk’s best work, but make no mistake about it, he has been the driving force behind some rather profound techno-cultural advancements.
His most ambitious may be Neuralink: An interface directly between the human brain and a computer chip that futurists have both yearned for and feared.
Musk has been publicly optimistic about making advancements in this cutting edge endeavor, but a recent revelation from inside the FDA has many wondering if it’s all just a show.
On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness.
Yet the company, founded in 2016, didn’t seek permission from the U.S. Food and Drug Administration (FDA) until early 2022 – and the agency rejected the application, seven current and former employees told Reuters.
The rejection has not been previously reported. In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, the staffers said. 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 employees said.
As for the path forward…
A year after the rejection, Neuralink is still working through the agency’s concerns. Three staffers said they were skeptical the company could quickly resolve the issues – despite Musk’s latest prediction at a Nov. 30 presentation that the company would secure FDA human-trial approval this spring.
Besides the very real medical and mental health risks involved in the trials, there are persistent ethical concerns about the melding of man and machine in such a way.
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