Neuralink, the brain-computer interface company founded by Elon Musk, recently received the Food and Drug Administration’s “breakthrough device” designation for its experimental implant, Blindsight. This significant development marks a big step forward in the treatment of blindness, even allowing individuals who have lost both of their eyes or optic nerves to regain some form of their vision. Musk also claims that the device has the potential to help those who have been blind from birth, as long as their visual cortex remains intact.

So, how does it work? Blindsight functions by implanting a microelectrode array into the visual cortex, the area of the brain that is responsible for processing visual information. This array then stimulates neurons, which in turn generate visual images for the patient. While the initial vision produced by Blindsight is expected to have a low resolution that’s similar to early computer graphics, Musk envisions it evolving into something even more advanced. According to a post he shared on X (formerly Twitter), it “has the potential to be better than natural vision,” with the possibility of allowing users to see in infrared or UV.

This designation, however, does not guarantee that Blindsight is safe or ready for widespread use. An FDA spokesperson emphasized that the breakthrough device tag is designed to speed up the development and review process, but that the technology still must meet rigorous safety standards before it can be marketed. In general, the purpose of the FDA program is to accelerate the approval process for medical devices that offer new treatment avenues for life-threatening or irreversibly debilitating conditions. So far, Blindsight is one of 58 devices to receive this designation in 2024.

Musk’s ambition is to use this technology not only to restore vision, but also to help people with other severe disabilities. For example, Neuralink has made substantial progress with other brain-computer interface technologies. Earlier this year, the company successfully implanted its chip in a patient with quadriplegia, allowing them to control video games with their mind. This development is part of the company’s broader mission to create a platform capable of interacting with every part of the human brain.

Neuralink is not alone in the brain-computer interface space and does face some competition in getting to their goal. Other companies, such as Neurable, are working on similar technologies aimed at enhancing cognitive performance and brain health. However, Neuralink’s breakthrough with Blindsight has put the company in the spotlight, especially as it prepares for future clinical trials and further developments in its bid to transform the field of healthcare.

The future of brain-computer interfaces appears promising, but much depends on how the technology progresses through the development pipeline and regulatory approvals. A timeline for the start of human trials has yet to be announced, but getting this breakthrough tag is one of the many critical steps for Neuralink, helping the company speed up the process of trial implementations.