AI4Eyes Completes FDA Registration and Listing for its Eye Care Platform, Opening the Path to U.S. Commercialization

Montréal medtech company lists its platform as a Class I, 510(k)-exempt medical device

MONTREAL, Nov. 11, 2026 /PRNewswire/ -- AI4Eyes Medical Technologies Inc. ("AI4Eyes") today announced that it has completed U.S. Food and Drug Administration (FDA) establishment registration and device listing for its eye care platform. The company can now commercialize the platform in the United States in accordance with applicable FDA regulations.

The milestone marks AI4Eyes' formal entry into the U.S. market, the largest eye care market in the world. It builds on the quality management and regulatory foundation the company has put in place to support the responsible deployment of clinical eye care.

"Entering the U.S. market represents a significant breakthrough for AI4Eyes," said Dr. Tara Akhavan, Director of AI4Eyes. "We built this platform around rigorous quality and regulatory standards, because clinicians need tools they can trust. We look forward to bringing it to eye care professionals across the United States and helping them deliver faster, more informed care to their patients."

AI4Eyes plans to accelerate commercial deployment, expand clinical and industry collaborations, and grow adoption among eye care professionals and healthcare organizations in the U.S. The company is also pursuing additional regulatory authorizations towards Canada, Europe, and Asia.

About AI4Eyes
AI4Eyes Medical Technologies Inc. is a Montréal-based medical technology company developing AI-powered diagnostic and treatment support solutions for eye care. Its platform helps clinicians capture, analyze, and interpret ocular data to support earlier detection and more efficient patient management. Learn more at www.aiforeyes.com.

FDA device listing: accessdata.fda.gov

SOURCE AI4Eyes Medical Technologies Inc.