Dr. Tara Akhavan

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

Leading U.S. commercialization

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 1 hour ago

Notable Quotes

"Entering the U.S. market represents a significant breakthrough for AI4Eyes."

from AI4Eyes lists eye care platform with FDA, opening U.S. sales · Updated 1 hour ago

"We built this platform around rigorous quality and regulatory standards, because clinicians need tools they can trust."

from AI4Eyes lists eye care platform with FDA, opening U.S. sales · Updated 1 hour ago