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Neuralink Gets FDA Approval for Human Brain Chip Trials

The company says it will soon begin recruiting participants who want to control a computer with their minds.
By Ryan Whitwam
A hand holding the Neuralink chip
Credit: Neuralink

Elon Musk has been occupied with Twitter since acquiring the site for $44 billion last year, but a new CEO is expected to take the reins soon. That could give Musk time to return to Neuralink, the brain-computer interface (BCI) startup aiming to put a computer inside your head. The company has just gotten approval from the Food and Drug Administration (FDA) to begin testing its brain implant in humans.

The idea is that the Nuralink chip (above) will allow people with degenerative afflictions like Parkinson's and ALS could interact with technology they no longer have the manual dexterity to operate. Instead of poking touch screens and tapping buttons, a Neuralink user could just think about doing that. At least, in theory. The company has demoed the Neuralink device with monkeys that used them to control a pong-like video game, but moving to human trials comes with a lot more scrutiny.

There is a potential issue with the heaps of dead monkeys. To quote a great (and fictional) scientist, science cannot move forward without heaps. However, the rate at which Neuralink has gone through monkey test subjects has alarmed some animal welfare advocates. Neuralink denies any mistreatment, noting that new medical devices must be tested in animals before they can ethically be trialed in humans. Therefore, the primate work it conducted at the University of California Davis Primate Lab was necessary to reach this point.

This is a significant turnaround for the FDA, which initially rejected Neuralink's application for human trials in March 2023. At the time, the agency cited numerous safety concerns, like potential brain damage from the implantation and removal of thousands of tiny electrodes. The FDA was also concerned that the wireless charging battery could overheat and fail. Lithium fires inside the head are generally something to avoid. The FDA asked Neuralink to address these potential problems before proceeding. Musk said at the time he expected full approval this spring, and for once, that didn't turn out to be an overly optimistic Elon timeline.

Neuralink's next step is to recruit volunteers to try the brain implant, and it says that process will start soon. It will require invasive surgery to insert the aforementioned electrodes into the brain. Then, the Link implant will read and process neural signals, allowing users to control external devices like keyboards and mice over Bluetooth. [I can see our first how-to article now: "How to Pair Your Head With an External Mouse." -Ed.] This is a big step for Neuralink, but it's not the only company testing a BCI chip. A competing firm called Synchron got approval to move forward with human trials almost a year ago. No one has gotten final FDA approval to offer BCI implants to the public, but that day may be coming.

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