DIAGNOS Achieves ISO 13485 Certification
Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK) (OTCQB: DGNOF), a frontrunner in the early detection of critical health issues through its FLAIRE platform powered by Artificial Intelligence (AI), has announced that its quality management system is now fully compliant with the ISO 13485 standard and all relevant regulatory requirements for medical devices.
Importance of MDSAP Compliance
To commercialize its flagship product, CARA, DIAGNOS is required to undergo rigorous statutory quality compliance audits under the Medical Device Single Audit Program (MDSAP). This program provides a thorough approach to auditing quality management systems, aiming to improve the safety of medical devices.
Leadership Acknowledgments
Mr. Yves-Stephane Couture, Chief Operating Officer of DIAGNOS, expressed gratitude, stating, “I would like to take this opportunity to thank our employees for their hard work on this important process. Our clients expect our healthcare solutions to meet the highest quality standards, and DIAGNOS can now fulfill these expectations. Without this certification, we are not permitted to sell our solutions worldwide. This new certification also includes all new AI-based regulatory requirements approved by multiple governments.”
Growth in AI Healthcare Market
Mr. André Larente, President of DIAGNOS, noted, “This achievement comes at a time when Artificial Intelligence is rapidly advancing, and we aim to be at the forefront of the market. DIAGNOS has evolved from a company offering a single test to one that provides a comprehensive suite of tests, which has increased both profitability and patient satisfaction. A recent report estimates that the global AI in healthcare market, currently valued at USD 19.27 billion, will grow to USD 26.69 billion in the coming year and is projected to reach around USD 613.81 billion by 2034, reflecting a compound annual growth rate (CAGR) of 36.83% from 2024 to 2034.”
Regulatory Licensing Initiatives
DIAGNOS is actively seeking regulatory licenses in Canada and the USA for four additional modules designed to aid healthcare professionals in analyzing abnormal findings through Optical Coherence Tomography retinal images and grading Fundus images to detect signs of Retinopathy. The company is also focusing on addressing additional diseases using its retinal imaging technology.
About DIAGNOS
DIAGNOS is a publicly traded Canadian corporation committed to the early detection of critical health issues through its FLAIRE Artificial Intelligence (AI) platform. FLAIRE facilitates the rapid development of applications like CARA (Computer Assisted Retina Analysis), which enhances images for clearer retinal analysis. CARA serves as a cost-effective solution for real-time screening of large patient populations.
Frequently Asked Questions
What is the significance of the ISO 13485 certification for DIAGNOS?
The ISO 13485 certification confirms that DIAGNOS meets the stringent quality management standards necessary for medical devices, thereby enhancing its market capabilities.
What does CARA stand for and what is its purpose?
CARA stands for Computer Assisted Retina Analysis, a tool that employs AI to improve retinal images for more accurate analysis and detection of eye disorders.
How is DIAGNOS contributing to the field of healthcare?
DIAGNOS enhances healthcare outcomes by leveraging AI for early detection solutions aimed at critical health issues, including various eye diseases.
What markets is DIAGNOS targeting for expansion?
DIAGNOS is focusing on the US and Canadian markets to license its additional AI-powered healthcare modules.
What growth is projected for the AI healthcare market?
The AI healthcare market is anticipated to experience substantial growth, with projections indicating it could reach approximately USD 613.81 billion by 2034, reflecting a CAGR of 36.83% from 2024 to 2034.
