Elon Musk, the CEO of Telsa, X social media platform and co-founder of Neuralink has added another feather to his cap as the U.S. Food and Drug Administration (FDA) has given special clearance to Blindsight, an experimental implant.
The experimental implant received the US Food and Drug Administration’s “breakthrough device” designation on 17th September 2024. This status is given to certain medical devices that may significantly improve treatment or diagnosis of serious conditions.
Blindsight, though in its experimental stage is a device designed to restore vision, even for those who have lost both eyes and their optic nerve. Musk comparing the vision to Atari graphics, explained that the resolution will not be perfect but overtime, the technology will be better than natural sight.
In his words: “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.
“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.” He compared
Sharing the news of the approval on X, Musk wrote: “Much appreciated, US FDA!”
FDA acknowledged that the device is one of 58 to receive the designation this year and it’s aimed at “speeding up development, assessment and review for premarket approval” for medical devices that treat life-threatening or permanent conditions – as long as they meet safety standards, the agency’s website explained.
The New York Post revealed that when reached for comment: “an FDA spokesperson said the designation does not mean the device has been deemed safe and effective or that it can be marketed for medical purposes.
“The FDA assesses only whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current U.S. standard of care, for a life-threatening condition or irreversibly debilitating human disease or conditions, and where a device represents novel technology and no legally marketed alternative exists,” the spokesperson add
Although Blindsight is just one part of Neuralink’s technological innovations, it’s also developing brain-chip interfaces designed to assist paralyzed individuals, allowing them to control digital devices simply by thinking. So far two people had benefited from the successful brain-chip implant, using it to play video games and learn how to design 3D objects, with the approval from U.S. FDA.

SOURCES:
New York Post
X/@neuralink
X/@elonmusk
Reuters