AI4Eyes Medical Technologies Inc.

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AI4Eyes lists eye care platform with FDA, opening U.S. sales

Commercializing its eye care platform in the U.S.

AI4Eyes completed U.S. Food and Drug Administration establishment registration and device listing for its eye care platform on November 11, 2026. The Montréal company can now sell the system in the United States as a Class I device exempt from 510(k) premarket review.

Updated 2 hours ago