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MONA.health (Leuven, BE)

MONA DR

Belgian AI software that assesses fundus photos for diabetic retinopathy and maculopathy, so a nurse or assistant can carry out the screening.

Shared spot3of 14 professional tools with a GDPR profileOur summary of what the provider itself publishes about your data: whether the data is stored in the EU (2 points), whether there is a certification or GDPR safeguard (1) and whether the provider is established in the Netherlands or the EU (1). 3 or 4 points is Strong, 2 Good, 1 Limited, 0 Unknown. How we measure in eye care
GDPR: Limited
  • Provider based in the EU

Each tile is a professional tool in eye care, with the strongest GDPR profile on the left. 9 professional tools, like MONA DR, have a limited profile: they share this spot. Click through to that tool.

Priceon request
Free trialNot foundNot found on the provider's site when checked on 5 October 2026
Based inLeuven, BEEU
ModelNot publicproprietary image model (ensemble of convolutional networks), not a language model. CE-certified (MDR class IIa, 2023). Spin-off of KU Leuven and VITO. Ask about data location and conclude a data processing agreement.

Last checked: 5 October 2026 · How we check

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What it does

Detection of referable DR
Detection of diabetic maculopathy
Hard exudates (macular oedema)
Works with most fundus cameras
Referral advice within seconds
Report in web application
Whole process max. 3 minutes

Comparable in eye care

All 14 professional tools for eye care
Underlying model

own image model (ensemble of convolutional networks), not a language model. CE-certified (MDR class IIa, 2023). Spin-off from KU Leuven and VITO. Ask about data location and sign a data processing agreement. Many tools build on a large model from providers such as OpenAI or Anthropic. If in doubt, ask for the data processing agreement: it states where your data goes.

GDPR check for eye care

Questions about MONA DR

Which AI model does MONA DR use?
The maker of MONA DR does not publish which AI model sits underneath. Proprietary image model (ensemble of convolutional networks), not a language model. CE-certified (MDR class IIa, 2023). Spin-off from KU Leuven and VITO. Ask about data location and sign a data processing agreement.
How much does MONA DR cost?
on request. Check the current price on the provider's website; rates change often.
Who is MONA DR for?
MONA DR is aimed at eye care. It fits work such as taking and storing retinal photos and OCT scans, assessing them (fundus, OCT, visual field), screening for diabetic retinopathy, glaucoma and AMD and referring in good time, monitoring patients with wet AMD, and scheduling injection treatments.
What should I watch out for with AI in eye care?
Retinal images are health data and therefore special category personal data under the GDPR. Software that assesses images is a medical device: check the CE class under the MDR (usually IIa or IIb) and whether the algorithm has been validated for your camera or OCT device. Some tools are for 'research use only'. Choose a provider with a data processing agreement, ISO 27001 and ISO 13485, and clear data location (EU hosting or on-premise). Ask whether your images are used to train models. Opticians without a medical background may screen and refer, but not make a diagnosis. Explain in your client communication what an AI result does and does not mean. Under the EU AI Act, medical AI counts as high risk.

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