PUBLISHER: Grand View Research | PRODUCT CODE: 2132398
PUBLISHER: Grand View Research | PRODUCT CODE: 2132398
U.S. AI-enabled Ophthalmic Diagnostic Devices Market Size, Share & Trends Analysis Report By Cmponent, By Application, By End Use, And Segment Forecasts, 2026 - 2033
U.S. AI-enabled Ophthalmic Diagnostic Devices Market Summary
The U.S. AI-enabled ophthalmic diagnostic devices market size was valued at USD 64.3 million in 2025 and is projected to grow from USD 72.5 million in 2026 to USD 267.2 million by 2033, at a CAGR of 20.5% from 2026 to 2033. The market is experiencing rapid growth as healthcare providers increasingly adopt artificial intelligence to address rising demand for early detection of retinal diseases, improve screening efficiency, and overcome shortages of ophthalmologists in primary care settings. AI-enabled retinal imaging systems have evolved from decision-support tools to autonomous diagnostic platforms capable of identifying diabetic retinopathy and other sight-threatening diseases without specialist interpretation.
One of the primary drivers of market growth is the increasing prevalence of diabetes and diabetic retinopathy (DR) across the U.S., creating a substantial need for scalable screening solutions. According to the CDC's Vision and Eye Health Surveillance System (VEHSS), an estimated 9.6 million Americans were living with diabetic retinopathy in 2021, including approximately 1.84 million individuals with vision-threatening diabetic retinopathy. The prevalence is projected to increase substantially, with 14.7 million Americans expected to be affected by 2050, highlighting the growing burden of diabetes-related vision impairment in the U.S. This growing disease burden is encouraging healthcare systems to implement AI-enabled retinal screening technologies that can accurately identify patients requiring specialist referral while improving screening compliance in primary care settings.
Technological innovation and continued FDA clearances are further accelerating market expansion. In May 2024, the FDA cleared the Optomed Aurora handheld fundus camera integrated with AEYE Health's autonomous AI software (AEYE-DS), enabling portable diabetic retinopathy screening in virtually any healthcare setting across the U.S. The handheld system performs autonomous image analysis within approximately one minute, allowing screening to move beyond traditional eye clinics into primary care offices, pharmacies, and community health centers. This approval significantly broadened the accessibility of AI-enabled ophthalmic diagnostics and strengthened the commercialization of portable retinal imaging solutions in the U.S.
Moreover, AI-powered portable screening solutions are increasingly supporting early detection in primary care settings, reducing dependence on specialist availability while expanding access to vision care in underserved and remote communities. These innovations are strengthening the role of autonomous retinal diagnostics within routine diabetes management and preventive healthcare. To strengthen this trend, research presented at ENDO 2025 by investigators from the University of Texas Health Science Center at Houston introduced the Simple Mobile AI Retina Tracker (SMART), an AI-powered mobile retinal screening application capable of detecting and staging diabetic retinopathy with more than 99% accuracy in under one second. Designed to operate on internet-enabled devices, including basic smartphones, the solution enables primary care providers to incorporate retinal screening into routine diabetes care while expanding access to high-quality ophthalmic assessments in regions with limited specialist availability.
The market is also benefiting from growing clinical acceptance and supportive diabetes care guidelines. The American Diabetes Association (ADA) Standards of Care 2025 recognize FDA-authorized autonomous AI systems, including AEYE-DS (AEYE Health), EyeArt (Eyenuk), and LumineticsCore (Digital Diagnostics), as validated alternatives for diabetic retinopathy screening when appropriately implemented. The guidelines specifically recommend the use of retinal photography with remote reading or FDA-authorized AI algorithms to improve access to diabetic retinopathy screening, particularly in settings where access to eye care specialists is limited.
In addition, the ADA notes that prospective multicenter clinical trials have demonstrated the diagnostic accuracy of each of these autonomous AI platforms, supporting their integration into routine diabetes care. These AI-enabled screening services are also covered by most U.S. insurance plans, further reducing financial barriers to adoption and facilitating broader implementation across primary care and endocrinology practices. As healthcare providers continue to prioritize preventive care, early disease detection, and workflow automation, AI-enabled ophthalmic diagnostic devices are expected to play an increasingly important role in improving vision care outcomes across the U.S.
U.S. AI-enabled Ophthalmic Diagnostic Devices Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. AI-enabled ophthalmic diagnostic devices market report based on component, application, and end use:
- Component Outlook (Revenue, USD Unit, 2021 - 2033)
- Fundus Cameras
- OCT/OCTA Systems
- Ultra-widefield Imaging Systems
- Slit Lamp Imaging Systems
- Application Outlook (Revenue, USD Unit, 2021 - 2033)
- Diabetic Retinopathy Detection
- Age-related Macular Degeneration (AMD)
- Glaucoma Detection
- Diabetic Macular Edema
- Others
- End Use Outlook (Revenue, USD Unit, 2021 - 2033)
- Hospitals
- Specialty Clinics
- Diagnostic Centers
- Home Care
- Academic Centers
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Segment Definitions
- 1.2.1. Component
- 1.2.2. Application
- 1.2.3. End Use
- 1.2.4. Country scope
- 1.2.5. Estimates and forecasts timeline
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR's internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.4.5.1. Data for primary interviews in North America
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.2. Approach 1: Commodity flow approach
- 1.7.3. Volume price analysis (Model 2)
- 1.7.4. Approach 2: Volume price analysis
- 1.8. List of Secondary Sources
- 1.9. List of Primary Sources
- 1.10. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.2.1. Component outlook
- 2.2.2. Application outlook
- 2.2.3. End Use outlook
- 2.2.4. Country outlook
- 2.3. Competitive Insights
Chapter 3. U.S. AI-enabled Ophthalmic Diagnostic Devices Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.3. U.S. AI-enabled Ophthalmic Diagnostic Devices Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Bargaining power of suppliers
- 3.3.1.2. Bargaining power of buyers
- 3.3.1.3. Threat of substitutes
- 3.3.1.4. Threat of new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic landscape
- 3.3.2.3. Social landscape
- 3.3.2.4. Technological landscape
- 3.3.2.5. Environmental landscape
- 3.3.2.6. Legal landscape
- 3.3.1. Industry Analysis - Porter's
Chapter 4. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: Component Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: Component Movement Analysis
- 4.3. U.S. AI-enabled Ophthalmic Diagnostic Devices Market by Component Outlook (USD Million)
- 4.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
- 4.5. Fundus Cameras
- 4.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.6. OCT/OCTA Systems
- 4.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.7. Ultra-widefield Imaging Systems
- 4.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.8. Slit Lamp Imaging Systems
- 4.8.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: Application Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: Application Movement Analysis
- 5.3. U.S. AI-enabled Ophthalmic Diagnostic Devices Market by Application Outlook (USD Million)
- 5.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
- 5.5. Diabetic Retinopathy Detection
- 5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.6. Age-related Macular Degeneration (AMD)
- 5.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.7. Glaucoma Detection
- 5.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.8. Diabetic Macular Edema
- 5.8.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.9. Others
- 5.9.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: End Use Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. U.S. AI-enabled Ophthalmic Diagnostic Devices Market: End Use Movement Analysis
- 6.3. U.S. AI-enabled Ophthalmic Diagnostic Devices Market by End Use Outlook (USD Million)
- 6.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
- 6.5. Hospitals
- 6.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6. Specialty Clinics
- 6.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.7. Diagnostic Centers
- 6.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8. Home Care
- 6.8.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.9. Academic Centers
- 6.9.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. Competitive Landscape
- 7.1. Market Participant Categorization
- 7.2. Key Company Profiles
- 7.2.1. Digital Diagnostics Inc.
- 7.2.1.1. Company Overview
- 7.2.1.2. Financial Performance
- 7.2.1.3. Product/Service Benchmarking
- 7.2.1.4. Strategic Initiatives
- 7.2.2. Eyenuk, Inc.
- 7.2.2.1. Company Overview
- 7.2.2.2. Financial Performance
- 7.2.2.3. Product/Service Benchmarking
- 7.2.2.4. Strategic Initiatives
- 7.2.3. AEYE Health
- 7.2.3.1. Company Overview
- 7.2.3.2. Financial Performance
- 7.2.3.3. Product/Service Benchmarking
- 7.2.3.4. Strategic Initiatives
- 7.2.4. Optos
- 7.2.4.1. Company Overview
- 7.2.4.2. Financial Performance
- 7.2.4.3. Product/Service Benchmarking
- 7.2.4.4. Strategic Initiatives
- 7.2.5. Notal Vision, Inc.
- 7.2.5.1. Company Overview
- 7.2.5.2. Financial Performance
- 7.2.5.3. Product/Service Benchmarking
- 7.2.5.4. Strategic Initiatives
- 7.2.6. Carl Zeiss AG
- 7.2.6.1. Company Overview
- 7.2.6.2. Financial Performance
- 7.2.6.3. Product/Service Benchmarking
- 7.2.6.4. Strategic Initiatives
- 7.2.7. Canon Medical Systems
- 7.2.7.1. Company Overview
- 7.2.7.2. Financial Performance
- 7.2.7.3. Product/Service Benchmarking
- 7.2.7.4. Strategic Initiatives
- 7.2.8. Topcon Corporation
- 7.2.8.1. Company Overview
- 7.2.8.2. Financial Performance
- 7.2.8.3. Product/Service Benchmarking
- 7.2.8.4. Strategic Initiatives
- 7.2.9. Optomed
- 7.2.9.1. Company Overview
- 7.2.9.2. Financial Performance
- 7.2.9.3. Product/Service Benchmarking
- 7.2.9.4. Strategic Initiatives
- 7.2.10. Heidelberg Engineering
- 7.2.10.1. Company Overview
- 7.2.10.2. Financial Performance
- 7.2.10.3. Product/Service Benchmarking
- 7.2.10.4. Strategic Initiatives
- 7.2.1. Digital Diagnostics Inc.
List of Tables
- Table 1. List of secondary sources
- Table 2. List of abbreviations
- Table 3. U.S. AI-enabled ophthalmic diagnostic devices market, by component, 2021 - 2033 (USD Million)
- Table 4. U.S. AI-enabled ophthalmic diagnostic devices market, by application, 2021 - 2033 (USD Million)
- Table 5. U.S. AI-enabled ophthalmic diagnostic devices market, by end use, 2021 - 2033 (USD Million)
List of Figures
- Fig 1. U.S. AI-enabled ophthalmic diagnostic devices market segmentation
- Fig 2. Market research process
- Fig 3. Data triangulation techniques
- Fig 4. Primary research pattern
- Fig 5. Market research approaches
- Fig 6. Value-chain-based sizing & forecasting
- Fig 7. Market formulation & validation
- Fig 8. Market snapshot
- Fig 9. Cmponent and application outlook (USD Million)
- Fig 10. End use outlook (USD Million)
- Fig 11. Competitive landscape
- Fig 12. U.S. AI-enabled ophthalmic diagnostic devices market dynamics
- Fig 13. U.S. AI-enabled ophthalmic diagnostic devices market: Porter's five forces analysis
- Fig 14. U.S. AI-enabled ophthalmic diagnostic devices market: PESTLE analysis
- Fig 15. U.S. AI-enabled ophthalmic diagnostic devices market: Component segment dashboard
- Fig 16. U.S. AI-enabled ophthalmic diagnostic devices market: Component market share analysis, 2025 & 2033
- Fig 17. Fundus cameras market, 2021 - 2033 (USD Million)
- Fig 18. OCT/OCTA systems market, 2021 - 2033 (USD Million)
- Fig 19. Ultra-widefield imaging systems market, 2021 - 2033 (USD Million)
- Fig 20. Slit lamp imaging systems market, 2021 - 2033 (USD Million)
- Fig 21. U.S. AI-enabled ophthalmic diagnostic devices market: Application segment dashboard
- Fig 22. U.S. AI-enabled ophthalmic diagnostic devices market: Application market share analysis, 2025 & 2033
- Fig 23. Diabetic retinopathy detection market, 2021 - 2033 (USD Million)
- Fig 24. Age-related macular degeneration (AMD) market, 2021 - 2033 (USD Million)
- Fig 25. Glaucoma detection market, 2021 - 2033 (USD Million)
- Fig 26. Diabetic macular edema market, 2021 - 2033 (USD Million)
- Fig 27. Others market, 2021 - 2033 (USD Million)
- Fig 28. U.S. AI-enabled ophthalmic diagnostic devices market: End use segment dashboard
- Fig 29. U.S. AI-enabled ophthalmic diagnostic devices market: U.S. AI-enabled ophthalmic diagnostic devices market share analysis, 2025 & 2033
- Fig 30. Hospitals market, 2021 - 2033 (USD Million)
- Fig 31. Specialty clinics market, 2021 - 2033 (USD Million)
- Fig 32. Diagnostic centers market, 2021 - 2033 (USD Million)
- Fig 33. Home care market, 2021 - 2033 (USD Million)
- Fig 34. Academic Centers market, 2021 - 2033 (USD Million)
- Fig 35. Company categorization
- Fig 36. Company market position analysis
- Fig 37. Strategic framework
