American billionaire Elon Musk’s neurotechnology firm, Neuralink, is promising to give sight to people who are blind through a blindsight device, something – if achieved – would be a major medical breakthrough. On September 17, Neuralink announced, on its X page, that it received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for Blindsight – an experimental medical device (implant) it developed to help bring back sight to people who have lost it. The device is designed to restore vision by targeting the brain's visual cortex – an area in the outer layer of the brain that processes visual information – making sense of visual information and object recognition. This is made possible by bypassing the optic nerve and directly stimulating the visual cortex to create a visual perception, according to Musk. The US FDA’s breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and, as reported, preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. It is a process designed to expedite the development and review of drugs that are intended to treat a serious condition. We have received Breakthrough Device Designation from the FDA for Blindsight. Join us in our quest to bring back sight to those who have lost it. Apply to our Patient Registry and openings on our career page https://t.co/abBMTdv7Rh — Neuralink (@neuralink) September 17, 2024 Reacting to the US FDA’s decision, Musk said 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,” Musk said. “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 pointed out. Geordi La Forge is a fictional character who appeared in an American science fiction television series Star Trek: The Next Generation. La Forge had been blind since his birth and used a technological device that allowed him to see. 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... https://t.co/MYLHNcPrw6 pic.twitter.com/RAenDpd3fx — Elon Musk (@elonmusk) September 17, 2024 Neuralink was founded by Musk and a team of seven scientists and engineers. According to the International Agency for the Prevention of Blindness, an estimated 43 million people were blind as of 2020. Figures from the World Health Organization (WHO) show that as of August 10, 2023, globally, at least 2.2 billion people had vision impairment, pointing out that vision impairment poses an enormous global financial burden, with the annual global cost of productivity estimated to be US$ 411 billion.
