Eye disease screening solution receives MDR CE certification
Thirona, a company specializing in artificial intelligence for medical image analysis, has obtained CE MDR certification for its RetCAD Class IIa software for eye disease screening, confirming compliance with the highest standards required of suppliers medical solutions.
RetCAD is a CE (0344) certified software product using artificial intelligence that analyzes color fundus images to detect the presence of Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR). It assists eye care providers in the early diagnosis and classification of vision-threatening diseases. RetCAD uses state-of-the-art deep learning and computer vision technology, using large amounts of images graded by human specialists, to provide quantified clinical outcome measures.
With instantaneous analysis of every patient fundus examination using a clinically validated software system, initial screening procedures can be performed more efficiently and at least as accurately as when performed by human experts. Simplified visualization of exam analysis with heatmaps helps clinicians validate AI results and helps improve patient engagement in the prevention of serious vision problems and blindness.
RetCAD is distributed worldwide through integration partnerships with leading fundus camera vendors such as Topcon, Canon, Tomey and Nidek, as well as medical solution providers such as Delft Imaging and iCare. European MDR CE Class IIa certification proves Thirona’s highest quality assurance and long-term commitment as a trusted eye care technology partner.
The MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive (93/42/EEC) and includes more stringent standards and requirements to ensure improved clinical safety and reliability of products and solutions medical.
Mark van Grinsven, Head of Product Development at Thirona, said: “The new MDR regulations place much greater emphasis on the evaluation of clinical data, forcing AI companies to meet very stringent quality and safety requirements. strict. Thirona relies on clinical data available internally and on data provided by clinical partners, as we have always emphasized the importance of clinical evaluation and collaboration with clinical experts. Now that our clinical evaluation methods have also been refined and linked to risk management and post-market surveillance, we are proud to offer our customers a high performing, safe and reliable solution.
Lydia Pannekoek, Head of Quality Assurance at Thirona, added: “Quality and regulatory compliance have always been the cornerstone of our product development, alongside risk management, clinical validation and usability. . Already working with rigorous quality standards, we were able to obtain EU-MDR compliance for our quality management system and a first of our products quite quickly, in September 2020. RetCAD is already our third product with MDR certification.