Diagnos Inc., a leading Canadian company in artificial intelligence for early disease detection, has announced a significant milestone in its strategic expansion into the U.S. optometry market. The company has formally submitted a Pre-Submission (Q-sub) to the U.S. Food and Drug Administration (FDA) for its CARA System. This submission marks the first step towards obtaining regulatory clearance for the CARA System, a cloud-based platform designed to assist optometrists by analyzing retinal images for indicators of various retinal and systemic diseases. The initiative is supported by ORA LLC, known for their regulatory expertise and support in ophthalmic devices. This development positions Diagnos Inc. to enhance the efficiency and accuracy of eye care in the U.S., addressing a market with approximately 49,300 practicing optometrists.