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Monday, Sep 01, 2025

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Neuralink Receives FDA Approval for First-in-Human Clinical Study

Elon Musk's brain-implant company, Neuralink, has received U.S. Food and Drug Administration (FDA) approval to launch a first-in-human clinical study. The company plans to implant its brain chips in patients with severe paralysis to help them control digital devices with their minds.
Neuralink's chips are about the size of a quarter and are implanted into the brain through a small incision. The chips contain thousands of electrodes that can record and stimulate brain activity.

In animal trials, Neuralink's chips have been shown to help paralyzed monkeys control robotic arms and legs. The company hopes to achieve similar results in human trials.

The FDA's approval is a major milestone for Neuralink. The company has been working on its brain chips for several years, and the approval means that it can now begin testing them in humans.

Neuralink's clinical trial will be small, with only a few patients participating. The company will monitor the patients closely to assess the safety and effectiveness of its chips.

If the clinical trial is successful, Neuralink could begin selling its brain chips to the public within a few years. The company has said that it hopes to eventually use its chips to treat a variety of neurological disorders, including Alzheimer's disease, Parkinson's disease, and depression.

The FDA's approval is a major step forward for Neuralink and for the field of brain-computer interfaces. The technology has the potential to revolutionize the way we treat neurological disorders and give people with paralysis new abilities.
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