DIAGNOS Advances Regulatory Strategy for CARA in Key Markets: Updates on Health Canada, FDA, and SFDA Progress

Core Insights - Diagnos Inc. is advancing its AI platform CARA for early detection of eye-related health issues and is focused on securing regulatory approvals in Canada, the U.S., and Saudi Arabia [1][2][6] Regulatory Pathway - The company is actively working to meet the regulatory standards in three key jurisdictions: Canada, the U.S., and Saudi Arabia [2] - In Saudi Arabia, CARA has been formally submitted for marketing approval to the Saudi Food and Drug Authority (SFDA) [6] - In Canada, the company is engaged with Health Canada to align with medical device regulations and plans to submit a formal application for CARA in the current quarter [6] - In the U.S., after strategic meetings with the FDA, the company has clarified the requirements for obtaining 510(k) clearance, facilitating the path to commercialization [6] Company Overview - Diagnos Inc. is a publicly traded Canadian corporation focused on the early detection of critical eye-related health problems using Artificial Intelligence [3] - The company's goal is to enhance diagnostic accuracy, streamline workflows, and improve patient outcomes globally [3]