A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America.

Journal: NPJ digital medicine
Published Date: May 29, 2025

Abstract

This scoping review aims to identify regulator-approved ophthalmic image analysis artificial intelligence as a medical device (AIaMD) in three jurisdictions, examine their characteristics and regulatory approvals, and evaluate the available evidence underpinning them, as a step towards identifying best practice and areas for improvement. 36 AIaMDs from 28 manufacturers were identified - 97% (35/36) approved in the EU, 22% (8/36) in Australia, and 8% (3/36) in the USA. Most targeted diabetic retinopathy detection. 19% (7/36) did not have published evidence describing performance. For the remainder, 131 clinical evaluation studies (range 1-22/AIaMD) describing 192 datasets/cohorts were identified. Demographics were poorly reported (age recorded in 52%, sex 51%, ethnicity 21%). On a study-level, few included head-to-head comparisons against other AIaMDs (8%,10/131) or humans (22%, 29/131), and 37% (49/131) were conducted independently of the manufacturer. Only 11 studies (8%) were interventional. There is scope for expanding AIaMD applications to other ophthalmic imaging modalities, conditions, and use cases. Facilitating greater transparency from manufacturers, better dataset reporting, validation across diverse populations, and high-quality interventional studies with implementation-focused outcomes are key steps towards building user confidence and supporting clinical integration.

Authors

  • Ariel Yuhan Ong
    Institute of Ophthalmology, University College London, London, United Kingdom.
  • Priyal Taribagil
    Honorary Research Fellow, University College London, London, UK.
  • Mertcan Sevgi
    Institute of Ophthalmology, University College London, London, UK.
  • Aditya U Kale
    Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Eliot R Dow
    Department of Ophthalmology, Byers Eye Institute at Stanford, Palo Alto, CA, USA.
  • Trystan MacDonald
    Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
  • Ashley Kras
    Harvard Retinal Imaging Lab, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
  • Gregory Maniatopoulos
    Population Health Science Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Xiaoxuan Liu
    Birmingham Health Partners Centre for Regulatory Science and Innovation University of Birmingham Birmingham Reino Unido Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, Reino Unido.
  • Pearse A Keane
    National Institute for Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
  • Alastair K Denniston
    Centre for Patient Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham Reino Unido Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, Reino Unido.
  • Henry David Jeffry Hogg
    Population Health Science Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.

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