EU-MDR Class IIb certified · Autonomous AI

Scaling care for millions. Instantly.

The first EU-MDR Class IIb certified autonomous AI detecting serious eye diseases in seconds — Approved for use by any healthcare professional, not limited to ophthalmology expertise

CE MDR IIb IEC 27001:2023 EN ISO 13485:2016
The Technology

One retinal image. Multiple health insights.

Aireen's Diabetic Retinopathy and Age-related Macular Degeneration modules are EU-MDR Class IIb certified and available on the market today. Cardiovascular Disease Risk and neurodegenerative indications from the same single, non-invasive 45° fundus scan are currently under development.

45° retinal fundus scan analyzed by Aireen AI for diabetic retinopathy, age-related macular degeneration and cardiovascular disease risk indicators.
From a single 45° fundus scan

Aireen's AI analyzes one non-invasive retinal image and surfaces three independent clinical insights in seconds — without specialist review.

  • Diabetic Retinopathy — microaneurysms, hemorrhages, hard exudates, nerve fiber layer abnormalities and other signs of DR. On market
  • Age-related Macular Degeneration — drusen, pigment abnormalities and other early signs of AMD. On market
  • Cardiovascular Disease Risk — arteriolar narrowing, venular widening, AV nicking. In development

Diabetic Retinopathy (DR)

On market

AI detects microaneurysms, hemorrhages, hard exudates and other early signs of DR.

  • Microaneurysms
  • Hemorrhages
  • Hard exudates
  • Nerve fiber layer abnormalities

Age-related Macular Degeneration (AMD)

On market

AI identifies drusen, pigment changes and other early signs of AMD.

  • Drusen
  • Pigment abnormalities

Cardiovascular Disease (CVD) Risk

In development

AI analyzes vascular signs linked to increased CVD risk.

  • Arteriolar narrowing
  • Venular widening
  • AV nicking
Diabetic Retinopathy
Early detection can prevent vision loss.
Age-related Macular Degeneration
Early detection supports better outcomes.
Cardiovascular Disease Risk
Retinal biomarkers can indicate systemic vascular risk.
Solutions by Segment

One certified platform. Five tailored programs.

Select your segment to see the operating model, clinical evidence, and commercial impact built for your team.

For Ophthalmologists

Filter out the healthy. Reclaim your primary focus.

Aireen acts as an autonomous diagnostic triage filter. By shifting routine, high-volume diabetic retinopathy (DR) and age-related macular degeneration (AMD) screenings to an EU-MDR Class IIb certified AI, eye clinics eliminate administrative bottlenecks, reduce waiting room saturation, and focus human expertise strictly on complex specialized clinical care .

Sensitivity, Specificity & PPV

vs. Expert Panel Baseline

Aireen vs. expert panel
sensitivity94.0%
specificity90.7%
PPV86.3%
Retina specialists vs. expert panel
sensitivity87.1%
specificity81.2%
PPV74.1%
General ophthalmologists vs. expert panel
sensitivity90.1%
specificity76.6%
PPV70.4%

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).

Clinical Workflow

Capture to certified report

  1. 1
    Capture standard 45° fundus image
    Single/multiple image(s) per eye, compatible with most commonly used fundus camera. 
  2. 2
    Instant AI  quality check & disease analysis
    Encrypted upload, AI grading across DR severity levels and AMD analysis, ISO 27001:2023 audit trail.
  3. 3
    Clinical report in seconds
    Clear result without the need for ophthalmologist interpretation.
Clinical workflow

How it works

  1. Tabletop fundus camera used to capture a retina scanClinician capturing a retina scan with a handheld fundus camera
    Step 1

    Retina Scan Capture & Cloud Upload

    Handheld or tabletop fundus camera scan.

  2. Retinal fundus image analyzed by Aireen
    Step 2

    Data Validation & AI Analysis

    Aireen performs instant quality check and feedback to operator.

  3. PDF
    Report
    ICDR
    R0
    R1
    R2
    R3
    R4
    Step 3

    Report Provided

    Report indicating presence or absence of symptoms.

Hardware agnostic

Aireen is hardware independent — the software can work with any validated fundus image from various camera manufacturers meeting the defined technical criteria.

Clinical Validation & Security

Evidence enterprise medicine can stand behind.

Validated
Clinically proven 

Several multi-center clinical trials have been performed for DR and AMD indications.

CE IIb
EU-MDR Class IIb Certified

Legally valid autonomous medical diagnostic capabilities across the EU.

ISO 27001
IEC 27001:2023

Full international enterprise information security framework compliance.

ISO 13485
EN ISO 13485:2016

Certified quality management system for design, development, configuration, sale, installation and service of software devices.

Book a Demo

See certified retinal AI in your environment.

Tell us who you are and we'll route you to the right specialist — clinical, commercial or integration.

Headquarters
Vodičkova 736/17,  110 00 Prague, Czech republic

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