by Daniel Parker, RDPFS Contributor:
The U.S. Food and Drug Administration (FDA) has issued a “breakthrough device designation” for a new experimental implant hoped to have the potential to restore vision. The designation, awarded to Neuralink for a device called Blindsight, “is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices currently under development.” In an article for MobiHealthNews, Jessica Hagen states that “Blindsight implants a microelectrode array into the visual cortex of a person’s brain. The array then activates neurons, which then provide the individual with a visual image.” Devin Coldewey, in an opinion article for TechCrunch, explains further that the breakthrough device designation is “a voluntary program that developers can apply to that, if granted, ‘offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase.’” According to an article from Reuters, a clinical trial will enroll three participants and take place over several years. Elon Musk, CEO of Neuralink, said in a post on X: “The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see. [I]t will even enable those who have been blind from birth to see for the first time.” Coldewey points out that, on the other hand, versions of the electrode array technology in Blindsight have already been in use and that, while it improves on earlier iterations by increasing the density of electrodes, “it faces the same fundamental drawbacks,” in terms of low resolution related to the scarcity of electrodes. More information can be found at the links above.
