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Argus II, the company’s first device, provided artificial vision for >350 profoundly blind patients and was FDA-approved under a Humanitarian Device Exemption; it is now discontinued. The successor Orion system completed an initial 6-year clinical study in 2024, demonstrating encouraging safety and efficacy for artificial vision in the profoundly blind. Orion has FDA Breakthrough Device designation[1][4][6][9].
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