Neuralink secures FDA approval to test futuristic device that could enable vision in the blind

The evaluation process can now speed up and agency's review will be faster

Serving tech enthusiasts for over 25 years.
TechSpot means tech analysis and advice you can trust.

Forward-looking: Neuralink is on a mission to transform its brain-computer interface into a lifeline for patients suffering from severe medical conditions. Now, the company is working to bring another groundbreaking innovation to those living without their natural vision.

Neuralink recently announced that it has received "Breakthrough Device Designation" from the FDA for Blindsight, a device designed to restore vision to those who can no longer see. According to Elon Musk, Blindsight has the potential to enable people who have lost both eyes, or even their optic nerves, to "see" the world again.

Musk explained that as long as the visual cortex in the brain remains intact, Blindsight could work in conjunction with Neuralink's brain implant to allow people who have been blind since birth to experience sight for the first time. However, expectations should be tempered, as the initial results are likely to resemble "low-resolution," Atari-like graphics.

The technology has the potential to surpass natural human vision, offering additional capabilities such as "seeing" in infrared or ultraviolet portions of the electromagnetic spectrum. Musk referenced the fictional visor technology used by Lieutenant Geordi La Forge in Star Trek: The Next Generation, which scans the electromagnetic spectrum and converts it into visual input transmitted to the brain via the optic nerve.

// Related Stories

• Scientists create tiny robots that can safely treat brain aneurysms
• Neuralink study participant plays Counter-Strike 2 using only his mind

The FDA's Breakthrough Device Designation is reserved for medical devices that may offer "significant advantages" over existing treatments for serious health conditions. This designation allows the FDA to allocate additional resources for faster reviews and provide more frequent, real-time feedback to facilitate development.

If the device can meet initial expectations, it could hit the market sooner. While the designation does not guarantee approval, it highlights the device's potential for "substantial" patient benefits and accelerates its path to commercialization, the FDA notes. Neuralink is currently seeking individuals with quadriplegia to participate in new clinical trials for its brain implants.

Despite being affected by the erratic behavior of its controversial founder, the California-based neurotech company has demonstrated promising results with its brain-computer interface. Neuralink recently reported that a second patient regained the ability to play online video games after suffering a spinal cord injury. Restoring sight to individuals with no functioning retina or optic nerve would be yet another, truly groundbreaking achievement.