DIAGNOS Achieves ISO 13485 Certification for Growth
DIAGNOS Achieves ISO 13485 Certification
Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK) (OTCQB: DGNOF), a leader in early detection of critical health issues through the use of its FLAIRE platform based on Artificial Intelligence (AI), announces that its quality management system fully complies with ISO 13485 standard and applicable regulatory requirements for medical devices.
Importance of MDSAP Compliance
As part of the commercialization requirements for its flagship product CARA, DIAGNOS must undergo thorough statutory quality compliance audits under the Medical Device Single Audit Program (MDSAP). MDSAP is a comprehensive approach to auditing quality management systems aimed at enhancing the safety of medical devices.
Leadership Acknowledgments
“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,” stated Mr. Yves-Stephane Couture, Chief Operating Officer of DIAGNOS.
Growth in AI Healthcare Market
“This achievement arrives at a time when Artificial Intelligence is expanding rapidly, and we aim to lead the market. DIAGNOS has transitioned from a one-test company to offering a suite of tests, thus increasing profitability and patient satisfaction. A recent report estimates that the global AI in healthcare market, valued at USD 19.27 billion, will grow to USD 26.69 billion in the upcoming year and is expected to reach approximately USD 613.81 billion by 2034, reflecting a CAGR of 36.83% from 2024 to 2034,” highlighted Mr. André Larente, President of DIAGNOS.
Regulatory Licensing Initiatives
DIAGNOS is currently pursuing regulatory licenses in Canada and the USA for four additional modules to assist healthcare professionals in analyzing abnormal findings through Optical Coherence Tomography retinal images and grading Fundus images to identify signs of Retinopathy. The company is actively working on additional diseases using retinal imaging technology.
About DIAGNOS
DIAGNOS is a publicly traded Canadian corporation dedicated to early detection of critical health problems based on its FLAIRE Artificial Intelligence (AI) platform. FLAIRE enables rapid development of applications such as CARA (Computer Assisted Retina Analysis), which provides improved image enhancement for clearer retinal analysis. CARA is a cost-effective solution for real-time screening of large patient volumes.
Frequently Asked Questions
What is the significance of the ISO 13485 certification for DIAGNOS?
The ISO 13485 certification validates that DIAGNOS adheres to high-quality management standards required for medical devices, enhancing its market capabilities.
What does CARA stand for and what is its purpose?
CARA stands for Computer Assisted Retina Analysis, which utilizes AI to enhance retinal images for better analysis and detection of eye disorders.
How is DIAGNOS contributing to the field of healthcare?
DIAGNOS is improving healthcare outcomes by utilizing AI to provide early detection solutions for critical health problems, such as various eye diseases.
What markets is DIAGNOS targeting for expansion?
DIAGNOS is targeting the US and Canadian markets for licensing its additional AI-powered modules in healthcare.
What growth is projected for the AI healthcare market?
The AI healthcare market is expected to grow significantly, with forecasts estimating it will reach approximately USD 613.81 billion by 2034, with a CAGR of 36.83% from 2024 to 2034.
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