Elon Musk’s Neuralink Startup Receives FDA Approval for First In-Human Brain Chip Implant Clinical Study
Elon Musk’s Neuralink neurotechnology startup company received approval from the U.S. Food and Drug Administration (FDA) on Thursday to launch its first in-human clinical study.
“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said on Twitter.
Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons, and would allow humans to save and replay memories, saying that “the future is going to be weird.”
Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.
Seven current and former FDA employees told Reuters earlier this year that 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.” (Read more from “Elon Musk’s Neuralink Startup Receives FDA Approval for First In-Human Brain Chip Implant Clinical Study” HERE)
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