Elon Musk's Neuralink has FDA approval to put chips in humans' brains. Here's what's next.

Elon Musk's SpaceX recently launched the biggest and most powerful rocket into flight, even though it did not make it into orbit. But the world's richest man isn't content on expanding his sci-fi inspired technology into just the cosmos.

Neuralink, the tech startup co-founded by Musk, also wants to embark on a fantastic voyage into the brain. Two weeks ago, the company announced it had gained approval from the Food and Drug Administration to begin trials to implant brain chips into humans.

We don't know when trials will begin, but there's plenty of buzz around Neuralink's development of a brain-computer interface. Neuralink's valuation has risen to about $5 billion from $2 billion two years ago, Reuters reported this week.

It will likely be years before many patients get the Neuralink treatment, but that isn't stopping investors. "The valuation has risen significantly the last few years in the private markets and as use cases and execution is proven out by Neuralink investors will take more notice," said Daniel Ives, an analyst with Wedbush Securities. "Musk has had the historic golden touch with Tesla and SpaceX so Neuralink is on the radar of the tech world over the coming years."

"Neuralink is just in the early stages of massive innovation and laying the groundwork for another revolutionary technology coming out of the Musk ecosystem," he said.

What does the Neuralink brain chip actually do?

Neuralink's goal with its human trials is to eventually enable a person with paralysis to use a computer or phone with their brain activity alone. The Neuralink 1 implant actually includes multiple chips, a wireless battery and other electronics hermetically sealed within a device about the size of a large coin.

Several dozen ultra-thin threads protrude from the implant; those go directly into the brain. Signals from the implant are sent via Bluetooth to, and decoded by, a brain-computer interface (BCI), which would allow a person to, for instance, control an onscreen cursor or move a robotic limb.

"The first thing that we're going after is a wireless implanted chip that would enable someone who is a … tetraplegic or quadriplegic to control a computer, or mouse, or their phone, or really any device … just by thinking. This obviously would be a massive enabler, make life way easier for them," Musk said in an online chat in 2021. "I'd say it's like a Fitbit in your skull with tiny wires that go to your brain."

Beyond helping paralyzed patients regain some mobility and communicate without typing, Neuralink's longer-term goals include helping restore full mobility and sight.

How is the Neuralink chip inserted into the body?

Neuralink has created a surgical robot, especially designed to embed the implant and its 64 ultra-thin flexible connected threads upon which are 1,024 electrodes that record neural activity.

The robot has five built-in camera systems and uses optical coherence tomography for non-invasive imaging of brain tissue. The robot uses a needle as thin as a human hair, which inserts the "threads exactly where they need to be," Neuralink's site says.

Elon Musk's Neuralink: Tech billionaire wants people to control computers with their minds.

When will Neuralink begin testing the chips in humans?

Neuralink tweeted on May 25 about getting FDA approval to launch its first in-human clinical study. The achievement "represents an important first step that will one day allow our technology to help many people," the company said. "Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!"

During a presentation on Nov. 30, 2022, Musk said the company could begin implanting its chips in humans as part of a clinical trial in about six months.

But it could take a decade or so for Neuralink to make its brain implant available commercially. Kip Ludwig, the former program director for neural engineering at the National Institutes of Health, told Reuters he "optimistically" expected Neuralink to take at least 10 more years to commercialize its brain implant.

Neuralink also faces regulators' investigations into its research protocols, including the treatment of animals – rats, mice, sheep, pigs and monkeys have been used in research – and whether the company illegally and unsafely packed and shipped chips, removed from monkeys' brains and contaminated with infectious, dangerous pathogens, Reuters reported.

The FDA rejected Neuralink's application for human trials in 2022, citing several issues including the potential for the implant’s threads to migrate to other areas of the brain, Reuters reported.

The company is currently looking to hire a neurosurgeon, animal welfare and animal care specialists, an institutional animal care and use committee (IACUC) administrator, a clinical trial manager, and fill a slew of other tech jobs.

Based on Musk's handling of Twitter, some experts were surprised at the FDA's granting Neuralink approval for human trials.

Laura Cabrera, a neuroethicist at Penn State’s Rock Ethics Institute, told The Guardian she was surprised in the agency's decision. “Is he going to see a brain implant device as something that requires not just extra regulation, but also ethical consideration?” she said. “Or will he just treat this like another gadget?”

The investigations may be a sign there's "sloppy work" happening at Neuralink, said L. Syd M Johnson, a neuroethicist at the Center for Bioethics and Humanities in SUNY Upstate Medical University, to The Guardian. “There are some ethical concerns about privacy, anytime you’re using a brain device,” she saidzi. “Things to look out for are: will Neuralink have access to the brain data of the people that they implant these devices in? What are they going to do with it? And how are they going to protect user privacy?”

Here's a breakdown on Neuralink's research so far.

In August 2020, Musk demonstrated brain activity in a pig with the chip implanted and in April 2021, Neuralink demonstrated how a chip-implanted monkey could play Pong.

During November 2022 event, which was livestreamed, Musk said, “I could have a Neuralink device implanted right now, and you wouldn’t even know,” CNBC reported.

Eventually, Neuralink would make it so “You’ll be able to save and replay memories. … The future is going to be weird,” he said at a 2020 event.

Brain tech competition: Elon Musk's Neuralink approved for human trials, Austin's Paradromics close behind

Other companies are competing with Musk's Neuralink in brain technology

Neuralink may be the hot name, but many researchers have been studying interfacing brains with computers for decades, as a way to treat brain injuries and other applications.

Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos have invested in Synchron, which is headquartered in Brooklyn with offices in Melbourne, Australia, and has already had its brain-computer interface (BCI) tested in humans. The journal JAMA Neurology published in January a one-year study of four patients who had the company's Stentrode inserted through the blood vessels into the brain's motor cortex. An antenna in the chest transmits brain data it collects.

The patients had no health issues and were able to send texts, emails, and shop online, according to the research. The technology can help patients with paralysis get "the return of things we take for granted, like texting loved ones or turning on a light,” said Synchron founder Tom Oxley.

Blackrock Neurotech, in Salt Lake City, Utah, has been testing brain implants for nearly two decades, and says its device has helped people who are paralyzed control limbs, prosthetics and devices. The company is working to secure FDA approval, Reuters reported.In Austin, Texas, Paradromics hopes to begin in-human trials as early as the first half of next year with its own device, the Connexus Direct Data Interface. Tiny electrodes implanted in brain tissue capture and transmit neural signals which are then decoded and sent to external devices through a transmitter installed under the skin in the chest.

This technology may seem like something out of "Total Recall" but it's already happening. More than 150,000 people living in the United States have a type of brain implant called deep brain stimulators used to treat tremors caused by movement disorders such as Parkinson's, said Matt Angle, the CEO who founded Paradromics in 2015.

Those implants are more invasive than the types Paradromics and Neuralink are developing. "If you're getting it so you can play Nintendo Switch, I would say that's probably a bad choice. But if you're getting this because you have ALS and you're losing the ability to talk to your family, it's a really easy decision," Angle said.

Contributing: Bailey Schulz and Kara Carlson of the USA TODAY Network and The Associated Press.

Follow Mike Snider on Twitter: @mikesnider.

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This article originally appeared on USA TODAY: Musk's Neuralink got FDA approval for brain chips in human trials