DIAGNOS Advances CARA Regulatory Strategy

BROSSARD, Quebec, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in applying techniques in Artificial Intelligence (AI) for the early detection of eye-related health issues, is pleased to provide an update on the regulatory pathway for its AI platform, CARA. This follows the acceleration plan announced on October 8, 2025.

DIAGNOS Inc. has made significant strides in advancing its regulatory strategy for its CARA (Computer-Assisted Retinal Analysis) medical imaging technology. The company is focusing on key markets and has provided updates regarding its progress with health authorities in Canada, the United States, and China.

Health Canada has accepted DIAGNOS' application for CARA, allowing the company to begin the next steps in the approval process. This marks a critical milestone for DIAGNOS, as obtaining regulatory approval is essential for commercializing its technology. The CARA is designed to assist in the diagnosis of retinal diseases, a key area of focus for the company, particularly in light of the increasing prevalence of conditions such as diabetic retinopathy.

In the United States, DIAGNOS is actively working with the Food and Drug Administration (FDA). The company has submitted the necessary documentation that aligns with the FDA's requirements. Given the stringent nature of FDA regulations, DIAGNOS is taking a systematic approach to navigate the approval process. Efforts to engage with FDA representatives demonstrate the company's commitment to ensuring compliance and facilitating the potential for market entry in the lucrative U.S. healthcare sector.

Furthermore, DIAGNOS has also been in discussions with the Shanghai Food and Drug Administration (SFDA) to address the requirements for regulatory approval in China. The Chinese market represents a substantial opportunity for DIAGNOS, given the country’s rapidly evolving healthcare landscape and growing demand for advanced medical technologies. The strategic engagement with SFDA is essential for the company's aspirations to expand its footprint in Asia.

DIAGNOS’ CARA technology leverages artificial intelligence to enhance the diagnostic process, providing healthcare professionals with more efficient tools to detect and classify retinal diseases. With a focus on improving patient outcomes, CARA aims to streamline the workflow in ophthalmology practices and reduce the time needed for diagnosis.

Overall, DIAGNOS' advancements in regulatory strategy and communication with major health authorities represent a critical phase in the company's trajectory. As it continues to gain approvals in key markets, stakeholders remain optimistic about the potential for CARA to transform retinal disease diagnosis and improve healthcare access for patients worldwide.