Thirona, a company specialising in artificial intelligence for medical image analysis, has been granted a MDR CE certification for its class IIa RetCAD software for eye disease screening, confirming compliance with the highest standards required for medical solutions providers.
RetCAD is a CE (0344) certified software product using artificial intelligence that analyses colour fundus images for the presence of Age-related Macular Degeneration (AMD) and Diabetic Retinopathy (DR). It assists eye care providers in early diagnosis and grading of the vision threatening diseases. RetCAD uses state-of-the-art deep learning and computer vision technology, utilising large amounts of human-specialist graded images, to provide quantified clinical outcome measures.
Having every patient fundus examination instantly analysed with a clinically validated software system, initial screening procedures can be done more efficiently and at least as accurate as when conducted by human experts. Simplified visualisation of the examination analysis with heat maps supports clinicians in validating the AI results and helps improve patient engagement in the prevention of severe eyesight problems and blindness.
RetCAD is distributed worldwide through integration partnerships with major fundus camera vendors such as Topcon, Canon, Tomey and Nidek, as well as medical solutions providers such as Delft Imaging and iCare. The Class IIa European MDR CE certification proves the highest quality assurance and the long-term commitment of Thirona as trusted technology partner for eye care.
The MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive (93/42/EEC) and includes more strict standards and requirements to ensure improved clinical safety and reliability of medical products and solutions.
Mark van Grinsven, head of product development at Thirona, said: “The new MDR regulation puts much stronger emphasis on evaluation of the clinical data, requiring AI companies to meet very stringent quality and safety requirements. Thirona builds upon clinical data available in-house and data provided by clinical partners, as we have always put emphasis on the importance of clinical evaluation and collaboration with clinical experts. Now that also our methods for clinical evaluation have been further 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, quality assurance manager at Thirona, added: “Quality and regulatory compliance has always been the key building block of our product development, next to risk management, clinical validation and usability. Working already with rigorous quality standards, we were able to obtain the EU-MDR compliance for our Quality Management System and a first of our products relatively quickly, back in September 2020. RetCAD is already our third product with MDR certification.”
