DIAGNOS Successfully Completes the Renewal of US-FDA Medical Device Establishment Registration

DIAGNOS Inc. (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Quebec-based company focused on the early detection of eye-related health issues through Artificial Intelligence (AI), announced the successful completion of its annual registration with the U.S. Food and Drug Administration (FDA) for its medical device establishment. This renewal allows DIAGNOS to continue its operations in the U.S. market, ensuring compliance with regulatory standards. The company also reaffirmed that the legacy version of its medical image management and processing system, CARA, remains cleared for commercialization in the United States.

Looking ahead, DIAGNOS is actively working on a new version of CARA, which will include advanced algorithms for detecting additional eye-related diseases. The company is in the regulatory approval process for these enhancements, as previously announced in a release dated January 13, 2026.

Furthermore, DIAGNOS revealed plans to amend the expiry date of 5,228,668 stock warrants, initially set to expire on April 25, 2026, to September 25, 2026. This amendment is part of a non-brokered private placement of units first announced on October 25, 2024. The exercise price of these warrants, set at $0.40 per common share, will remain unchanged, pending acceptance by the TSX Venture Exchange and the execution of formal documentation.

DIAGNOS continues to leverage AI to enhance diagnostic accuracy, streamline healthcare workflows, and ultimately improve patient outcomes on a global scale. The company emphasized that all amounts mentioned are in Canadian dollars and included a disclaimer regarding forward-looking information, cautioning that actual results may differ from projected outcomes. For more information, interested parties can visit www.diagnos.com and www.sedarplus.com.

DIAGNOS Inc. (TSX Venture: ADK, OTCQB: DGNOF) has recently made significant strides by successfully completing its renewal of the U.S. FDA Medical Device Establishment registration. This critical step enhances the company's operational capabilities in the U.S. market, specifically in the artificial intelligence-driven eye health detection sector. The company's existing CARA system, which is already cleared for commercialization in the U.S., provides a competitive foundation on which DIAGNOS aims to build with its future iterations that will incorporate advanced algorithms for detecting various eye-related diseases.

Investors should recognize that this FDA registration renewal demonstrates DIAGNOS's commitment to regulatory compliance and market viability, which are crucial for attracting partnerships and increasing penetration into the healthcare systems. As the healthcare industry increasingly embraces AI technologies for diagnostics, DIAGNOS is strategically positioned to leverage this trend. The ongoing development of a new version of CARA, while navigating the necessary regulatory approvals, further underscores its potential to meet unmet medical needs in a growing market.

Moreover, the company’s recent move to amend the expiry date of a substantial number of stock warrants indicates a proactive approach to ensure liquidity and investor engagement. The decision to extend the expiry of these warrants until September 25, 2026, may positively impact shareholder sentiment by providing additional time for stakeholders to capitalize on their investments, particularly given the growth prospects tied to emerging product offerings.

In summary, DIAGNOS is poised for a meaningful growth trajectory supported by its regulatory achievements and ongoing innovation in eye health detection. Investors considering DIAGNOS should keep a close eye on upcoming product launches and FDA approvals, as these will undoubtedly be key drivers of market performance in the near future.