Rooted in Clinical Evidence. Trusted by Scientific Experts.
Every Aireen indication is grounded in multi-center clinical evaluation, gold-standard ground truth, and a regulatory framework that authorizes the software to act autonomously.
Validated against an expert panel.
Aireen DR was evaluated head-to-head against general ophthalmologists and retinal specialists on imagery within multicentre clinical trial— proving consistent autonomous performance across hardware and care settings.
Sensitivity, specificity & PPV vs. expert panel
Multi-center clinical trial (n=1,274 diabetic patients) comparing Aireen DR with retinal specialists and general ophthalmologists against a gold-standard expert panel. According to the EU-MDR regulatory process, Risk class IIb (CE 2265).
Peer-reviewed and conference evidence.
Request a link to any of the following publications featuring Aireen. We'll share the reference directly with qualified clinical, regulatory and partnership stakeholders.
Real-World Evaluation of AI-Based Diabetic Retinopathy Screening Using the Optomed Aurora Handheld Fundus Camera
Published in
Diabetes Technology & Therapeutics
Screening of Diabetic Retinopathy with Aireen: High Sensitivity and Agreement with Ophthalmologists
Published in
EASD Media Centre
Comparison of the Aireen System with Telemedicine Evaluation by an Ophthalmologist — A Real-World Study
Published in
Clinical Ophthalmology (Šín et al., 2025)
Deep integration with medical academia.
Aireen's scientific direction is shaped by leading clinicians and academic researchers across ophthalmology, internal medicine and neurology.
Science validated. Engineering delivered.
See the hardware-agnostic architecture, DICOM/PACS-native workflows and IEC 27001:2023 governance that bring this science into everyday clinical practice.