FDA calls Neuralink’s Blindsight a ‘breakthrough’ as Musk eyes vision for blind

Elon Musk’s brain-chip startup, Neuralink, continues to push the boundaries of medical technology with its latest announcement.

The company revealed that its experimental vision-restoring implant, Blindsight, received the prestigious “breakthrough device” designation from the U.S. Food and Drug Administration (FDA) on Tuesday.

This puts the device in a group of cutting-edge medical technologies designed to treat serious health conditions, possibly speeding up its approval process.

Nonetheless, although the news has sparked much enthusiasm, what Blindsight is capable of—particularly in terms of regaining sight to its optimal capacity—is not as easy as Musk’s declarations imply.

Blindsight: How it works and its ambitious goals

Blindsight is Neuralink’s bold attempt to help people who have lost their vision regain some sense of sight, even for those who have lost both eyes and their optic nerve.

Musk shared his excitement on X, stating that this breakthrough will “enable even those who have lost both eyes and their optic nerve to see.” However, Neuralink has remained quiet on the timeline for human trials.

The Blindsight device functions by implanting a microelectrode array directly into the visual cortex of the brain. The array activates neurons based on input from an external camera which produces a visual image. It could also, in theory, provide a form of artificial vision for people who have never been able to see at all, such as those who have been born blind.

This is not the first time this kind of technology has been tried—similar devices have been used for the past decades to support vision in some partially sighted persons.

However, what makes Neuralink different from other brain-computer interface projects is that the company is attempting to add more electrodes to the implant, which, in theory, could increase the vividness of the users’ visions.

But despite these advances, it remains an open question as to how much “sight” Blindsight will actually restore.

The main challenge is the limited number of electrodes in current systems. With only a few electrodes, what a person might “see” would be more like small flashes of light rather than a clear image.

Neuralink’s approach is to increase the number of electrodes to improve this, but it still has major hurdles in producing realistic vision for users.

Challenges and skepticism surrounding vision restoration

Despite Musk’s excitement regarding the device, experts do not recommend considering Blindsight as a means of curing blindness. First, there is the issue of how the brain interprets visual information.

In individuals who were blinded because of an injury or illness and had their vision restored, their brain may still have the pathway to process information visually.

However, for a person who was born blind, such pathways may never fully form. Thus, even with such an advanced device as Blindsight, the brain may simply fail to interpret signals in visual terms properly.

As reported by TechCrunch , critics also contend that Musk’s vision for the sight to be “like Atari graphics” is quite an illusion. Adjusting to brain devices is difficult and even confusing for those who have never seen them before.

While those with recent vision loss might regain some sight, the brain may struggle to interpret the new signals in those blind from birth.

Restoring vision isn’t just about seeing light; it involves recreating depth, detail, and color, which is far more complex than simply connecting a camera to the brain. Musk’s claim needs to be tempered with this reality.

Neuralink’s potential impact and future of blindness treatments

Despite these challenges, Neuralink’s work in the field of brain-computer interfaces is still groundbreaking. Founded by Elon Musk in 2016, the company has made significant strides in developing implantable chips designed to help disabled individuals regain movement, communication, and even vision.

The FDA’s breakthrough designation for Blindsight signals that the technology holds considerable promise and could contribute to future treatments for blindness.

Currently, Neuralink is testing another implant in humans, and this one is expected to enable paralyzed individuals to navigate digital technologies using their brains.

As it stands, Blindsight is a work in progress, but the advancements made with Neuralink’s other technologies could assist in the refinement and application of the vision-recording implant.

Last year, as part of efforts on innovative technologies, 145 medical devices received the breakthrough designation from the FDA in 2023.

Neuralink’s Blindsight also falls into this esteemed category, but it still has a long way to go in adopting regulatory approval and broader clinical application.

Future trials and tests are expected to last for a few years as the specialists assess its efficacy and side effects in people.