Elon Musk’s New Device, Enabling Blind People To See, Put on Fast Track by FDA

Elon Musk scored an FDA win on Tuesday in his company’s “quest to bring back sight to those who have lost it.” Neuralink, a neurotechnology company founded by Mr. Musk, announced in a statement on X that it had “received Breakthrough Device Designation from the FDA” for its Blindsight device.“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” Mr. Musk wrote on X in a description of the device. “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”He said that the vision from the device will be low resolution at first but has potential to improve greatly. “To set expectations correctly, the vision will at first be low resolution, like Atari graphics, but eventually it has the potential to be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge,” he said. La Forge was a fictional character in the television series Star Trek: The Next Generation played by Levar Burton. The character was blind from birth but was able to see using high-tech glasses. It’s not the first time Mr. Musk has said the Blindsight implant has potential to be better than regular vision. Earlier this year, he said that its resolution will “be low at first” but “ultimately may exceed normal human vision.” Research from the University of Washington disputed that claim, saying that without a significant breakthrough, “the vision provided by Blindsight and similar projects will remain fuzzy and imperfect — no matter how sophisticated the electronic technology.” Mr. Musk’s Neuralink made headlines earlier this year when it successfully implanted a brain chip into a man, Noland Arbaugh, who was paralyzed from the shoulders down. After the implant, Mr. Noland was able to operate computers and play online games using his brain, as the Sun noted. The FDA describes its Breakthrough Devices Program as a “voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” It aims to allow “timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.”

Elon Musk’s New Device, Enabling Blind People To See, Put on Fast Track by FDA

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