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 under 60 seconds — with no manual specialist review required.

CE MDR IIb ISO 27001:2022 < 60s result
Fundus Camera · 45°Live
Retinal fundus photograph
Image qualityExcellent · 98%
Certified Report · PDF
Diabetic RetinopathyNot detected
AMDEarly signs · refer
Image QualityPass
Processing time42 s
Result ID · AIR-2026-08471Download
The Technology

The Human Retina: The Gateway to Preventive Health

The retina is the only place in the body where symptoms of major chronic diseases are visible non-invasively. Aireen uses advanced neural networks trained on over 1,000,000 expertly annotated scans to identify pathologies instantly.

Diabetic Retinopathy

Autonomous detection of referable diabetic retinopathy from a single 45° fundus image per eye. CE-marked EU-MDR Class IIb medical device.

  • 94.0% sensitivity in 1,274-patient multi-center trial
  • Built-in image-quality gating
  • Instant referral classification
AI Inference
Neural network trained on 1,000,000+ annotated retinal scans
Layers
152
Params
240M
Centers
40+
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 surgical 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 pathologies and surgical interventions.

Clinical Sensitivity

vs. Expert Panel Baseline

Aireen Autonomous AI94.0%
General Ophthalmologists90.1%
Retinal Specialists87.0%

Multi-center prospective trial, n=1,274 diabetic patients, ground-truth set by retinal expert panel.

Clinical Workflow

Capture to certified report

  1. 1
    Capture standard 45° fundus image
    Single image per eye, any compatible fundus camera. Automatic quality validation at capture time.
  2. 2
    Instant AI cloud validation & quality check
    Encrypted upload, AI grading across DR severity levels and AMD signs, ISO 27001:2022 audit trail.
  3. 3
    Certified autonomous report in under 60 seconds
    EU-MDR Class IIb certified PDF — zero specialist review or sign-off required. Hand directly to the patient.
Clinical Validation & Security

Evidence enterprise medicine can stand behind.

94.0%
Sensitivity

Multi-center clinical trial on 1,274 diabetic patients vs. an expert panel.

CE IIb
EU-MDR Class IIb Certified

Legally valid autonomous medical diagnostic capabilities across the EU.

ISO 27001
ISO/IEC 27001:2022

Full international enterprise information security framework compliance.

3 Steps
Scan → AI Triage → Report

Scan capture, cloud validation & AI triage, certified PDF report delivery.

Step 01
Scan Capture
Single 45° fundus image per eye on any compatible camera.
Step 02
Cloud Validation & AI Triage
Quality gate + neural network inference in seconds.
Step 03
Certified PDF Report
Instant, legally valid diagnostic report — no review needed.
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 17, Prague, Czechia

By submitting you agree to be contacted about Aireen products. We follow ISO/IEC 27001:2022 information security practices.