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Article History

Received: 20 August 2024

Accepted: 12 December 2024

First Online: 19 December 2024

Competing interests

: M.D.A. reports the following conflicts of interest: patents and patent applications assigned to the University of Iowa and Digital Diagnostics relevant to the subject; Director, consultant, shareholder, Digital Diagnostics Inc; Executive Secretary, Healthcare AI Coalition, Washington DC; Treasurer, Collaborative Community on Ophthalmic Innovation, Washington DC; member, American Academy of Ophthalmology (AAO) AI Committee; member, AI Workgroup Digital Medicine Payment Advisory Group (DMPAG) of the American Medical Association.; P.T.L. and C.J. received fees from Digital Diagnostics for statistical consultancy; M.K. is employee of Hologic Inc and former Director, Congressional Black Caucus Health Braintrust; NS and MB declare no competing interests. J.C.F. is shareholder of Digital Diagnostics. Disclosure forms provided by the authors are available with the full text of this article. Patents and patent applications that may be affected by this study are: assigned to University of Iowa (all: inventor M.D.A.): issued 7,474,775, Automatic Detection of Red Lesions in Digital Color Fundus Photographs; issued 7,712,898, Methods and Systems for Optic Nerve Head Segmentation; issued 8,340,437, Methods and Systems for Determining Optimal Features for Classifying Patterns or Objects in Images; issued 9,924,867, Automated Determination of Arteriovenous Ratio in Images of Blood Vessels; issued 9,814,386, Systems and methods for alignment of the eye for ocular imaging; issued 11,935,235 Diagnosis of a disease condition using an automated diagnostic model; application 20230419485-A1, Autonomous Diagnosis Of A Disorder In A Patient From Image Analysis; issued 11,676,700; Data aggregation, integration and analysis system and related devices and methods; application 63/557,296 Manifold foundational machine-learning model for classifying disease states.