Validated AI Screening for Vision-Threatening Conditions.

Per-encounter deliverables

• Per-patient classification: Positive / Negative / Undetermined
• DR positive split into MILD or MORE THAN MILD (Moderate / Severe / Proliferative)
• ICDR severity level per left and right eye
• Heatmaps highlighting regions that drove each prediction
• Downloadable clinical PDF report per analysis
• Built-in image-quality gating with retake prompt

International Clinical DR severity

1. 0
   No apparent DR

   No abnormalities
2. 1
   Mild non-proliferative DRMild

   Microaneurysms only
3. 2
   Moderate non-proliferative DRMore than mild · Referable

   More than just microaneurysms; less than severe NPDR
4. 3
   Severe non-proliferative DRMore than mild · Referable

   4-2-1 rule met; no proliferative signs
5. 4
   Proliferative DRMore than mild · Referable

   Neovascularization and/or vitreous/preretinal haemorrhage

Any "more than mild" finding is flagged as referable for ophthalmology follow-up per current guidelines.

Indications & population

• DR screening — Adults (Type 1 or Type 2 diabetes) who have not yet been diagnosed with diabetic retinopathy.
• AMD detection — Adults aged 50+ who have not yet been diagnosed with age-related macular degeneration.
• Input — Digital 45° colour fundus image(s) from a certified fundus camera; full-colour, ≥24-bit depth, including fovea and optic disc.
• Contraindications — Children under 18 years of age; Optical media opacification (changes in the cornea, cataract), tremor or narrow pupil due to which
  an evaluable retinal image cannot be taken; Patients in whom ocular fundus imaging for retinal evaluation is contraindicated;
  Previous laser treatment of the retina, injections into the eye, medical history of retinal inflammatory disease or any medical history of retinal surgery.
• Side effects — None. Aireen is software that analyses digital images taken by another certified medical device. It does not come into contact with the patient or operator in any way.