Neuralink gets FDA approval for human trials, but others are way ahead

Several years after Elon Musk's "aspirational" timeframe, Neuralink has announced it's received FDA approval for the first human trials of its brain-computer interface. But it's worth noting that another company has already done more than 50 implants.

Neuralink's first application to the FDA in 2022 was rejected on the grounds of safety concerns around the lithium battery, the potential for its tiny wires to move around in the brain, and uncertainties around if, and indeed how, Neuralink might be able to safely remove the implant without damaging brain tissue, according to anonymous current and former employees that spoke to Reuters earlier this year.

It seems it's been able to successfully address these concerns, and while the company is not yet seeking volunteers for the first trials, the regulatory door is now open.

The Neuralink N1 implant, a little larger than a US quarter, is designed to fit completely under the skin, replacing a chunk of a recipient's skull. With 64 tiny, flexible needle probes inserted into the brain tissue at precise points, it allows 1,024 channels of two-way communication between the brain and a computer chip.

The implant is then able to communicate wirelessly with external devices, at which point the patient starts being able to interface with smartphones, computers and the like using their mind alone. This takes some training, but as demonstrated by Neuralink's brain-chipped test monkeys, it works well enough to let them play pong, and operate a keyboard. The N1 also charges wirelessly, so nobody needs to plug their head in overnight.

The plan is to use these implants first in quadriplegic patients, as a way of giving them the ability to operate computers and control devices. Eventually, though, Musk wants to make these brain-computer interfaces a consumer product for anyone to buy, believing they'll open up much faster communication between humans and computers than the current keyboard and mouse standard allows.

In a purely speculative sense, that opens up a lot more than just a mind-controlled typing interface. You could theoretically use future versions to control additional bionic limbs, vehicles or robotic minions, complete with sensory feedback. You could have images or audio directly relayed to your visual or auditory systems without the need for speakers or displays, giving you the ability to tune into additional eyes and ears pretty much anywhere on your body, or indeed anywhere on Earth.

You could think messages and send them directly to somebody else's neural implant over a high-tech telepathic connection. You could potentially record the brain activity during your dreams, and re-experience them during waking hours. You could also potentially get hacked, which opens up all sorts of spooky possibilities. Things could certainly get pretty wild with a high enough brain-to-chip bandwidth, and a huge bandwidth is explicitly the goal here.

Surgically implanting these machines would be incredibly difficult by hand – "Imagine taking a hair from your head, and trying to stick it into Jell-o covered by Saran Wrap," said Neuralink Insertion Hardware team lead Christine Odabashian in an extensive presentation last December. "And doing this to a precise depth and position, and doing it 64 times within a reasonable amount of time."

As a result, the company has developed its own surgical robot, the R1, complete with breakthroughs in tiny needle design and sub-surface imaging that should allow the implant to be placed without removing the brain's protective dura layer. There may even be a CNC-style automated cutting machine to remove the skull chunk with robotic precision. It's unclear whether this is the process that'll be used in Neuralink's first clinical human trials.

But another company, Blackrock Neurotech in Salt Lake City, Utah, has already got its similar Neuroport Array chip implanted in human patients. This device pokes out through the skin, making it a lot less discreet, but it places some 96 "array" needles in the brain and opens up 600-odd channels of communication. Indeed, according to Blackrock, the Neuroport was first stuck into a human brain all the way back in 2004, and has been implanted more than 50 times now.

You can see a quadriplegic patient using it in the remarkable video below, to create digital art in Photoshop – a task that requires some pretty impressive control.

Blackrock says it's preparing the Neuroport Array for a commercial launch as a medical device. It's also now working on a much higher-bandwidth brain link: a 10-000-plus channel interface called the Neuralace, which it plans to make available to researchers by 2024. This flexible mesh, thinner than an eyelash, is designed to conform to the complex shape of the brain, and its porous shape allows cellular fluids and biomolecules to pass through it, which the company hopes will reduce immune responses and inflammation.

“If our BCI today can help people move and feel again with only six hundred channels, imagine what we can do with ten thousand or more,” said Florian Solzbacher, Blackrock co-founder and president. “We are actively imagining new therapies–for anxiety, depression, and other neurological disorders–that this technology will enable. This is a glimpse of what’s possible in the future of BCI.”

You can catch a glimpse of Neuralace in the video below.

Source: Neuralink