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Musk’s Neuralink gets FDA’s breakthrough device tag for ‘Blindsight’ implant

(Reuters) -Elon Musk’s brain-chip startup Neuralink said on Tuesday its implant aimed at restoring vision received the U.S. Food and Drug Administration’s “breakthrough device” designation.

The FDA’s breakthrough tag 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 experimental devices.

© Reuters. A smartphone with a Neuralink logo displayed is placed on a computer motherboard in this illustration taken on May 15, 2024. REUTERS/Dado Ruvic/Illustration

The experimental device, known as Blindsight, “will enable even those who have lost both eyes and their optic nerve to see,” Musk said in a post on X.

Neuralink is separately testing an implant designed to give paralyzed patients the ability to use digital devices by thinking alone, a prospect that could help people with spinal cord injuries.

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