The FDA’s breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions
Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials.Elon Musk ’s brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration’s “breakthrough device” designation.
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. Founded in 2016 by Musk and a group of engineers, Neuralink is building a brain chip interface that can be implanted within the skull, which it says could eventually help disabled patients to move and communicate again, and also restore vision.
The startup 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.
Development Neuralink Request Vision Musk Fda Devices U.S. Food And Drug Administration FDA Elon Musk
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