The company needs to perform clinical trials in humans before it can get FDA approval for general medical use.

Elon Musk’s brain chip startup, Neuralink, is preparing to launch its first clinical trials in humans. The founder, Elon Musk, tweeted last year; “First Neuralink product will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs.”

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Previous animal trials

The chip is successfully tested on animals such as; monkeys and pigs. Pigs and monkeys have similar anatomy to humans, including their fat distribution, and organ placement. Hence, they are used in clinical trials which implies that if something works in an animal model, it has a higher possibility of working in actual humans.

In testing out the pigs’ Neuralinks, the team put implants in their brains and placed them onto treadmills to observe their walking. With the chip implant, the scientists could compare their estimates for exactly how the pigs’ limbs would align while walking, against the actual positioning of their legs.

Neuralink is hiring a clinical trial director as it prepares for clinical trials in humans

Neuralink has a new job vacancy for a clinical trial director, a position that could help the company move towards its goal of starting clinical trials in humans. The company needs to perform clinical trials in humans before it can get Food and Drug Administration (FDA) approval for general medical use. The clinical trial process would start with a feasibility study to get a first look at how the device works in a small number of people. Then, because the device is high-risk and hasn’t been previously used in people, the company would need FDA approval to launch a larger-scale trial. According to the job posting, the clinical trial director would be responsible for interactions with regulators like the FDA.

Source: Guardian


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