CIUSSS du Nord-de-l'Île-de-Montréal

New Capabilities

Official evaluator for the AI4Eyes Avisé project

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