Neuralink’s Blindsight gets FDA breakthrough status for vision

Elon Musk has announced that his neurotechnology company, Neuralink, has secured US Food and Drug Administration (FDA) ‘breakthrough device’ status for its brain chip aimed at restoring vision, even for those who have been blind since birth. The experimental device, called Blindsight, could revolutionise the treatment of blindness by interfacing directly with the brain.

In a post on X (formerly Twitter), Musk stated, “The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see. Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.” 

Sharing a photo of ‘Star Trek: The Next Generation’ actor LeVar Burton, whose character Geordi La Forge used a futuristic visor to see, Musk further stated, “To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.”

The FDA’s breakthrough status is given to certain medical devices that can treat or diagnose life-threatening conditions. It aims to speed up the development and review of devices currently under development.

Neuralink’s Mission and Technology

Founded in 2016, Neuralink’s primary mission is to build a brain-computer interface (BCI) that helps patients with debilitating neurological conditions. The company is focusing on restoring autonomy to people with spinal cord injuries, amyotrophic lateral sclerosis (ALS), and now, vision loss. Neuralink’s breakthrough device status for Blindsight signifies progress in achieving these ambitious goals.

In January 2024, Neuralink conducted its first human implantation of the BCI. The implant detected neural signals, enabling the participant to use the system for applications such as playing online chess and Sid Meier’s Civilisation VI. This marks a significant milestone in making BCI technology available to potentially restore autonomy to millions of individuals with unmet medical needs.

Neuralink is also developing a brain implant to help paralysed patients control digital devices using only their thoughts. One of the first patients to receive this device has successfully used it to play video games and create 3D objects. The ongoing study will involve three patients over the next several years, further assessing the device’s effectiveness and long-term potential.

The N1 Implant and Telepathy

Neuralink’s long-term goal is to create a generalised input/output platform capable of interfacing with various brain regions. The first step towards this is the N1 Implant, an intracortical BCI implant designed to record neural activity through 1,024 electrodes distributed across 64 flexible leads. These electrodes are thinner than human hair and can be precisely placed in the brain, thanks to Neuralink’s R1 Robot, which performs delicate surgical insertion.

The N1 Implant wirelessly transmits neural data to an external device, where the Neuralink application decodes the information into actions, such as moving a cursor on a computer screen. The implant is powered by a rechargeable onboard battery and is implanted beneath the scalp, making it cosmetically invisible and functionally seamless.

Neuralink refers to the capability it is developing for people with quadriplegia to regain digital autonomy as ‘Telepathy.’ This could allow users to control digital systems like computers and smartphones solely through thought, opening up new possibilities for individuals with severe physical disabilities.

What is Next for Neuralink?

Neuralink’s breakthrough device designation for Blindsight is a promising step toward revolutionising neurotechnology. The company is committed to tackling brain and central nervous system disorders by developing innovative solutions that restore functionality to those with significant medical challenges. With ongoing trials and continuous development, Neuralink is edging closer to bringing its visionary technology to the mainstream, where it could change millions of lives.

As Musk hinted in his X post, while early applications of the technology may have limited capabilities, the potential for future advancements is enormous. These include the ability to perceive different wavelengths of light and significantly improve the quality of life for those with visual impairments or neurological conditions.