The Morning After: FDA reportedly denied Neuralink's request to begin human trials of its brain implant
It apparently cited ‘dozens’ of safety issues.
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. That’s looking increasingly unlikely.
– Mat Smith
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