Diagnos Inc. Advances Regulatory Pathway for CARA AI Eye Health Platform in Key Global Markets

Diagnos Inc. has provided an update on the regulatory pathway for its CARA artificial intelligence platform designed for early detection of eye-related health issues. The corporation confirmed progress across three targeted jurisdictions following its previously announced acceleration plan. This regulatory advancement represents a critical step toward making the AI-powered diagnostic tool available to healthcare providers and patients in key global markets.

The company has made a formal submission to the Saudi Food and Drug Authority for marketing approval of the CARA platform. This submission marks a significant milestone in the company's international expansion strategy and demonstrates the growing global recognition of AI's potential in healthcare diagnostics. Simultaneously, Diagnos is engaged in ongoing discussions with Health Canada, with a formal application expected to be submitted this quarter. The Canadian regulatory pathway represents an important opportunity in the company's home market.

In the United States, Diagnos has clarified 510(k) requirements with the U.S. Food & Drug Administration, positioning CARA for potential commercialization in the world's largest healthcare market. The 510(k) clearance process is a critical regulatory step for medical devices in the U.S., and this clarification provides a clearer roadmap for the company's regulatory strategy. Additional information about the company's regulatory progress and corporate developments is available through regulatory filings at www.sedarplus.com.

The CARA platform utilizes artificial intelligence to assist healthcare clinicians in detecting critical eye-related health problems at earlier stages. By leveraging advanced algorithms, the technology aims to provide more information to healthcare professionals, potentially enhancing diagnostic accuracy, streamlining clinical workflows, and improving patient outcomes. The platform's development aligns with growing global interest in AI applications within healthcare, particularly in areas where early detection can significantly impact treatment success rates.

Diagnos is a publicly traded Canadian corporation dedicated to early detection of critical health problems through technological innovation. The company's focus on eye-related conditions addresses a significant healthcare need, as many vision-threatening conditions show better outcomes when detected and treated early. The regulatory progress announced represents tangible steps toward making this technology available to healthcare providers who could benefit from enhanced diagnostic tools. For investors and stakeholders seeking additional information about the company's developments, corporate updates are disseminated through various channels including the company's corporate website at www.diagnos.com.

The regulatory advancements in Saudi Arabia, Canada, and the United States demonstrate the company's systematic approach to bringing its AI technology to market. Each jurisdiction represents distinct regulatory frameworks and market opportunities, with successful navigation of these pathways essential for global commercialization. The simultaneous progress across multiple regions suggests coordinated regulatory strategy and resource allocation. As artificial intelligence continues to transform healthcare diagnostics, regulatory approval represents a crucial gatekeeper determining which technologies reach clinical practice and patient care settings.