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Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'

Engadget

Neuralink says the Food and Drug Administration has designated its experimental Blindsight implant as a "breakthrough device." The company is developing the technology in an attempt to restore blind people's sight. Manufacturers who apply to the FDA's voluntary breakthrough devices program and receive the designation from the agency are granted "an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase." Ultimately, a breakthrough device designation can accelerate development of a technology. Last year, the FDA gave the designation to 145 medical devices.


Neuralink gets FDA's 'breakthrough device' tag for Blindsight implant

The Japan Times

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 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 the development and review of devices currently under development. 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 did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment.