Neuralink's Blindsight brain implant gets one step closer to human trials

The company has just received Breakthrough Device Designation from the FDA for their "Blindsight" brain computer interface technology, fast tracking it's progress toward testing in human subjects

Image: Midjourney

Yesterday, Elon Musk’s company Neuralink announced that the US Food and Drug Administration has granted Breakthrough Device Designation to the company’s “Blindsight” device — a wireless Brain Computer Interface (BCI) designed to restore sight to people who have lost it, and even provide sight to people who were born blind.

While this designation doesn’t immediately green light in-human trials, it does put Neuralink on the fast track to testing the device in people, and it’s an important step toward a class of BCIs that have very real and accessible medical advantages.¹

At the same time, there’s a slew of hype around Blindsight that risks raising dangerously high expectations.

As I’m writing this, I’m heading to Hanover, New England to talk about BCIs at the annual Dartmouth Development Device Symposium — a leading forum for the medical device community. I was already planning to use Neuralink’s work on its “Telepathy” platform as an example of disruption in the field of BCIs through bringing a big tech mindset to medical device development. And yesterday’s announcement only serves to underline many of the points I will be highlighting.

Blindsight is designed to work by implanting thousands of electrodes in a patient’s visual cortex, and wirelessly connecting these to an AI-driven system that can convert signals from an external device such as a camera sensor, to inputs that the user’s brain interprets as images.

Musk is so optimistic about the technology that he is claiming that it will “enable those who have been blind from birth to see for the first time” and eventually have “the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths”

Despite his optimism though, there are serious scientific challenges to achieving this. As the University of Washington’s Ione Fine and Geoffrey Boynton wrote back in August, Musk’s claims rest “on the fallacy that neurons in the brain are like pixels on a screen.”

Drawing on their own research, they note that “Sight restoration is not simply an engineering problem. Predicting what kind of vision a device will provide requires knowing how the technology interfaces with the complexities of the human brain.”

I suspect — and hope — that the scientists, engineers and physicians at Neuralink have a firmer grasp of reality than some of Musk’s more speculative rhetoric seems to suggest, and that they have an eye on developing medical devices that deliver what patients need within a responsible and ethical framework.

But I also suspect that, by using increasingly sophisticated AI with the Blindsight BCI, a lot more will be achievable than with more traditional approaches to “bionic eyes.”²

Even so, just how realistic are Musk’s claims of eyesight that transcends what most of us were born with? And how much of this is little more than a sci-fi fueled fever dream?

Reading Musk’s announcement on X, I couldn’t help recalling a scene in the movie Transcendence (a film where Musk also makes a cameo appearance), where advanced nanotechnology is used to miraculously give sight to someone who was blind from birth:

The technology is different to Neuralik’s, but the vision (if you’ll forgive the pun) is the same — that of a technological savior bringing sight to the blind (and, if you want to extend the association, enabling the lame to walk).

It’s a vision that’s reflected in Musk’s reference to Star Trek The Next Generation’s Geordie La Forge in his post on X (see above), and one that hints at savior complex-like aspirations to make make humans “better” than their messy and limited biology allows.

This led to my colleague Riz Virk commenting on X that “the Sci Fi feedback loop, the general topic of my PhD dissertation, continues on ... Star Trek and Neuralink for the latest iteration!”

There’s a very real sense here that Musk is being driven both by a desire to “fix” people he considers to be disadvantaged or disabled, and to do this by taking inspiration from science fiction — with the assumption that he (or rather, his extensive team of experts) can translate fiction into reality.

Putting aside the troublesome idea of “fixing” people, there is little to indicate that, just because someone can imagine possibilities that currently don’t exist like BCIs that enable the blind to see, all it takes to make them reality is a dash of advanced technological wizardry.

For instance, the scene above from the movie Transcendence is sheer nonsense. It’s not something that’s possible within the laws of physics, no matter how much wishful thinking is involved. And it ignores how nanotechology works, how the brain works, and how humans work with all of our physiological and psychological complexity.

The danger is that technologists who get caught up in Riz’s “Sci Fi feedback loop” similarly end up ignoring reality in the belief that they can transcend it.

The result in the case of Blindsight is rhetoric that goes far beyond what is likely to be possible, and visions of future technologies that risk raising hopes that are deeply unrealistic.

There’s also the danger of being so blinded by the technology that the complexities of ensuring access to devices, and long term support once patients have been implanted, are overlooked. As I was reminded when preparing for this week’s symposium, the idea that all you need for a successful medical device is a technology that works and patients who are willing to pay for it, is deeply nave.³ And as I and others ave pointed out, implanted medical devices come with a lifetime responsibility to patients.⁴ As Fine and Boynton note in their August article in The Conversation, “In our almost 20 years researching bionic eyes, we’ve seen the complexity of the human brain defeat company after company. Patients pay the cost when these devices fail, left stranded with orphaned technologies in their eye or brain.”

Of course, it could be argued that naive visions of the future are maybe what are needed to jolt society into exploring and developing new possibilities when it comes to BCIs. And even if Neuralink’s Blindsight only delivers on a fraction of what is being imagined, it could still lead to lead to very significant advances in the field.

But with such cutting edge medical technologies there’s a profound responsibility to do right by the people who are impacted by them. And this includes treading carefully when tempted to ignore reality in favor of a sci-fi dream — especially when there are plenty of people willing to believe the rhetoric, no matter what the evidence is to the contrary.

1. According to the FDA, “The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects our commitment to device innovation and protecting the public health.”

2. Unlike many other BCIs, Neuralink is part of a growing technology ecosystem that includes the development of next generation AI capabilities, an emphasis on utilizing vast amounts of data in novel ways, and massively scaling production and reducing cost through automation. I fully expect the company to synergistically leverage all of these as it develops, tests ad deploys its devices.

3. For example, in the US at least it’s deeply naive to assume that all you need to succeed is a technology that works and patients who will pay for it, while ignoring the supply chains, the economics, the policies, and the politics that surround medical care.

4. I write extensively about this in chapter 7 of Films from the Future.