Factbox-Elon Musk’s missed deadlines for FDA approval of Neuralink brain-chip trials

By Rachael Levy

(Reuters) – Several times since 2019, billionaire Elon Musk has predicted his brain-chip company, Neuralink, would soon secure FDA approval for human trials. But the company’s application was rejected in early 2022, Neuralink staffers told Reuters, and the company is still working through the agency’s concerns over the safety of the experimental implant.

Here is a history of Musk’s predictions of FDA clinical-trial approval:

July 2019: Musk says Neuralink is aiming to receive regulatory approval for human trials of brain implants by the end of 2020.

February 2021: Musk tweets: “Neuralink is working super hard to ensure implant safety & is in close communication with the FDA. If things go well, we might be able to do initial human trials later this year.”

April 2022: Musk tells an interviewer that “aspirationally” the company aims to get FDA approval to “do the first human implant this year.”

November 2022: Musk tweets: “We are now confident that the Neuralink device is ready for humans, so timing is a function of working through the FDA approval process.” He says at Neuralink’s livestreamed “show-and-tell” presentation that he expects the device to be in humans in six months, and that he considers it safe enough for his own children.

(Reporting by Rachael Levy)

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