Elon Musk’s Neuralink Blindsight gets FBA Breakthrough Device tag

Is Neuralink's Blindsight the key to restoring sight? With the FDA's "breakthrough device" designation, there's fresh hope on the horizon!

During the Neuralink presentation in late 2022, Elon Musk made some bold claims about Neuralink Blindsight. He suggested it could help blind people see. Naturally, this raised some eyebrows among experts who felt we weren’t quite there yet. Fast forward to now, and Neuralink has announced that their experimental implant aimed at restoring vision has received the US Food and Drug Administration’s “breakthrough device” designation. Could this be a ray of hope for those who’ve lost their sight or were born without it?

Keep reading to find out what the FDA Breakthrough Device designation means, what Neuralink’s Blindsight device is all about, and what you can look forward to!

FDA Breakthrough Device designation

Neuralink’s Blindsight went through a pretty intense process to get the FDA’s “breakthrough” designation. This label speeds up approval for devices that could help with life-threatening or seriously debilitating conditions, including those that Neuralink Blindsight aims to aid.

To qualify, Musk’s team had to show their device could be more effective than current treatments. It also needed to stand out by being a breakthrough technology, offering something new where no options exist, or being a major improvement over existing devices. The FDA found it was in the best interest of patients.

Neuralink’s Blindsight device

Back in January, Musk hinted that Neuralink’s latest product might focus on helping the blind and others with vision issues. He mentioned that the Neuralink chip could send “direct vision to the brain” by activating parts of the visual cortex, potentially restoring sight even when the optic nerve connecting the eye and brain is damaged.

“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” he said in a post on X. He also suggested that, as long as the patient’s visual cortex is intact, Neuralink could “enable those who have been blind from birth to see for the first time.”

While the possibilities seem groundbreaking, Neuralink’s technology is still in its experimental phase. When it might actually be ready is still unclear.

Neuralink Blindsight: What’s on the horizon?

When it comes to helping restore sight for the blind, it’s worth noting that Neuralink’s tech is currently only approved for closely monitored clinical trials. Even if things go smoothly in those trials—though that’s not a sure thing—we’re still looking at years before it could roll out as a medical device. Experts shared with Forbes that Neuralink’s lack of transparency makes it tough to gauge how their technology is progressing in real life. Updates tend to be pretty selective and often come through Musk’s livestreams and tweets, which can be a bit hit or miss when discussing Neuralink Blindsight.

For example, Musk shared on X that Blindsight might initially offer low resolution but could eventually surpass normal human vision. However, researchers from the University of Washington aren’t buying it. Ione Fine, the lead author and psychology professor, argues that Musk’s expectations are based on a misunderstanding of how brain implants actually work.

The team created a model simulating various cortical studies and found that, while a high-resolution image can be clear with 45,000 pixels, a similar setup using 45,000 electrodes would produce a blurry image. Fine explains that each electrode stimulates a single neuron, not a pixel, and that image clarity depends on how groups of neurons communicate in the brain.

While Musk is pushing the boundaries of visual implant technology, significant challenges remain. Scientists still don’t know how to decode the neural patterns necessary for clear vision, and the hope for perfect sight through Neuralink Blindsight might be a bit unrealistic.

The gist

It’s clear that while the potential for restoring vision is exciting, we’re still in the early stages. The FDA’s “breakthrough device” designation for Neuralink Blindsight is a hopeful sign, but we should temper our expectations with a dose of realism. The science behind it is complex, and challenges remain. I’ll be keeping an eye on developments, and I encourage you to do the same! Let’s see where this journey takes us—who knows what the future holds for those seeking to regain their sight?