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Will the US FDA grant Neuralink permission to implant a brain-machine interface device in a human before 1 January 2022?

Neuralink Corporation is an American neurotechnology company founded in 2016 by serial entrepreneur Elon Musk and others, developing implantable brain–machine interfaces (BMIs).

Since its founding, the company has hired several high-profile neuroscientists from various universities. By July 2019, it had received $158 million in funding (of which $100 million from Musk) and was employing a staff of 90 employees.

At that time, Neuralink announced that it was working on a “sewing machine-like” robot capable of implanting very thin "threads" into the brain, demonstrated a system that read information from a lab rat's brain via thousands of electrodes (many times more than the current maximum for systems used in human brains), and Musk announced an aspirational goal to start experiments with humans in 2020, pending FDA approval.

In the short term, the company aims to develop brain-machine interfaces to assist individuals with serious physical or neurological conditions; but the longer term goal of the company is to enable human-AI symbiosis and grant superhuman cognition to anyone who wants it, as well as a form of digital immortality.

Needless to say, if these more ambitious developments are actually possible, this technology would enable a radically different future to emerge. Enhancing human cognition may be the most important thing we could ever possibly do.

Elon Musk: "From a long-term existential standpoint... the purpose of Neuralink is to create a high-bandwidth interface to the brain such that we can be symbiotic with AI." (See 00:35 in the video.)

"It will enable anyone who wants to have superhuman cognition... anyone who wants." (See 02:55 in the video.)

"You will be essentially snapshotted into a computer at any time. If your biological self dies, you could probably just upload into a new unit. Literally." (See 05:55 in the video.)

You can watch the company's July 2019 presentation here, and read their paper An integrated brain-machine interface platform with thousands of channels here.

This question asks: Before 1 January 2022, will the US Food and Drug Administration grant regulatory approval allowing any device developed in whole or in part by Neuralink Corporation to be implanted into the brain of a living human?

You can find information on the FDA's Regulatory Overview for Neurological Devices here.

The implantation surgery need not actually occur by that date (or at all) in order for this question to resolve positively; this question focuses solely on whether regulatory approval will be obtained before 1 January 2022.

Note that any such regulatory approval that allows the implantation of any qualifying device in the brain of a living human will trigger a positive resolution, including (but not limited to) the grant of an Investigational Device Exemption or a Humanitarian Device Exemption. In particular, note that this question does not require full regulatory approval to market and sell any device to the public in order for a positive resolution.

Resolves ambiguously if the FDA is abolished before 2022, or if its role is changed such that regulatory approval is no longer required for this procedure.


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