Elon Musk’s brain implant company is approved for human testing. How alarmed should we be?

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The billionaire’s record has raised concerns over Neuralink’s ability to responsibly oversee the development of such an invasive device

The allegations have led to ongoing investigations of Neuralink from multiple government agencies and members of Congress, including an inquiry from the Department of Agriculture over allegations of animal abuse and the Department of Transportation over mishandling of bio-hazardous materials across state lines.

A screengrab from an August 2020 Neuralink livestream shows Musk standing next to the surgical robot.The FDA does not typically inspect laboratory facilities as part of their clinical trial application reviews, said Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA. He said it is impossible to know if it did in this case.

“There are some ethical concerns about privacy, anytime you’re using a brain device,” said Johnson.

Even as Neuralink secures FDA approval for clinical trials, it will be a long road for its products to reach consumers, experts say. After being approved for clinical research, companiesat least two rounds of trials before applying for FDA approval to commercially market a device.

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