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.” The FDA also prioritizes breakthrough devices for review. Ultimately, a breakthrough device designation
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