This paper is in the following e-collection/theme issue:

Systematic Review Protocols (335) Imaging Informatics (302) Decision Support for Health Professionals (1538) Computer-Aided Diagnosis (251) Clinical Information and Decision Making (1914) AI Applications in Biomedical Engineering (15)

Published on in Vol 13 (2024)

This is a member publication of University of Birmingham (Jisc)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/52602, first published .
AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices

AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices

AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices

Authors of this article:

Ariel Yuhan Ong1, 2 Author Orcid Image ;   Henry David Jeffry Hogg1, 3 Author Orcid Image ;   Aditya U Kale4, 5 Author Orcid Image ;   Priyal Taribagil1 Author Orcid Image ;   Ashley Kras6 Author Orcid Image ;   Eliot Dow7 Author Orcid Image ;   Trystan Macdonald4, 5, 8 Author Orcid Image ;   Xiaoxuan Liu4, 5, 8, 9 Author Orcid Image ;   Pearse A Keane1, 10, 11 Author Orcid Image ;   Alastair K Denniston4, 5, 8, 9 Author Orcid Image
Article Authors Cited by (5) Tweetations (4) Metrics

Journals

  1. Sevgi M, Ruffell E, Antaki F, Chia M, Keane P. Foundation models in ophthalmology: opportunities and challenges. Current Opinion in Ophthalmology 2025;36(1):90 View
  2. Hogg H, Brittain K, Talks J, Keane P, Kumar R, Lunn J, Lunn T, Nicholls R, Quilley A, Sinnett C, Maniatopoulos G. Intervention design for artificial intelligence-enabled macular service implementation: a primary qualitative study. Implementation Science Communications 2024;5(1) View
  3. Rimpi , Verma S, Pinky , Baldi A. Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization. Naunyn-Schmiedeberg's Archives of Pharmacology 2025;398(7):7697 View
  4. Ong A, Taribagil P, Sevgi M, Kale A, Dow E, Macdonald T, Kras A, Maniatopoulos G, Liu X, Keane P, Denniston A, Hogg H. A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America. npj Digital Medicine 2025;8(1) View
  5. Chhoker D, Yadav A, Sinha V. Ocular implants and inserts: revolutionizing drug delivery in ophthalmology. International Journal of Pharmaceutics 2025;685:126248 View