EyeArt
Overview
The EyeArt AI Eye Screening System by Eyenuk is an extensively validated artificial intelligence (AI) technology designed for the autonomous detection of diabetic retinopathy (DR). It enables healthcare providers, including those in primary care, diabetes centers, and optometric offices, to quickly and accurately identify patients with referable DR during a regular exam. The system autonomously analyzes patient retinal images, acquired using integrated fundus cameras, and provides easy-to-read reports in under 60 seconds. This allows for immediate, on-site screening without the need for expert human grading or eye dilation in most cases, streamlining the diagnostic process and improving patient compliance with annual screenings.
EyeArt is designed to integrate seamlessly into clinical workflows and is compatible with multiple camera models. Beyond diabetic retinopathy, the system also has CE marking in the European Union for the detection of age-related macular degeneration (AMD) and glaucomatous optic nerve damage. Eyenuk’s mission is to accelerate the world’s transition to predictive and preventative healthcare by screening every eye for timely diagnosis of life- and vision-threatening diseases.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Autonomous AI detection of more than mild and vision-threatening diabetic retinopathy (DR)
- Rapid results in under 60 seconds
- Compatible with multiple fundus cameras (Canon CR-2 AF, CR-2 Plus AF, Topcon NW400)
- Cloud-based system with thin client software
- Easy-to-read, actionable PDF reports
- Real-time image quality feedback and upgraded assessment module
- Can be operated by nurses or technicians with minimal training
- RESTful API for seamless integration with EHR/EMR/PACS
- ISO 13485:2016 Certified Quality Management System
- Detection of AMD and glaucomatous optic nerve damage (EU CE Mark Class IIb)
Use Cases
- Diabetic retinopathy screening in primary care settings
- On-site DR screening in diabetes centers and optometric offices
- Telemedicine-enabled diabetic eye screening
- Early detection and accelerated referral of vision-threatening DR
- Improving patient compliance with annual diabetic eye exams
- Screening for age-related macular degeneration (AMD) and glaucoma (EU)
What Physicians Need to Know
EyeArt provides an autonomous, rapid screening solution for diabetic retinopathy, significantly increasing access to timely detection, especially in primary care settings. While FDA-cleared for autonomous DR detection, for AMD and glaucoma, its autonomous capabilities are CE marked in the EU, but in the US, it serves as an assistive tool for ophthalmologists. Physicians should be aware of the specific camera models supported and ensure proper image acquisition for optimal accuracy. The system's high sensitivity for DR is crucial for identifying at-risk patients for referral, thereby helping to prevent vision loss.
EyeArt offers robust integration capabilities, including a RESTful API for seamless connection with Electronic Health Records (EHR), Electronic Medical Records (EMR), and Picture Archiving and Communication Systems (PACS). It is designed to fit into existing clinical workflows, enabling automated image analysis and report generation directly within a patient's regular exam, and has demonstrated successful integration into national health system EMRs.
Details
| Category | Ophthalmology AI |
| Pricing |
Contact us for pricing
|
| Deployment | Cloud-based with a thin client software installable on Windows PCs with internet access. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The EyeArt AI System received U.S. FDA 510(k) clearance (K200667 in August 2020, K223357 in June 2023) for autonomous detection of more than mild and vision-threatening diabetic retinopathy. It is cleared for use with Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400 cameras. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Family Medicine, Ophthalmology |
What the Web Says
EyeArt, developed by Eyenuk, is an FDA-cleared AI system designed for autonomous detection of diabetic retinopathy (DR) and vision-threatening DR. It analyzes retinal images to identify patients who need referral to an eye-care specialist, making point-of-care screening possible in various clinical settings without an ophthalmologist on-site. The system has been extensively validated in clinical studies, demonstrating high sensitivity and specificity for detecting DR.
Overall: PositiveStrengths
- High clinical accuracy with reported sensitivity above 90% for referable DR.
- FDA clearance as a Class II medical device provides regulatory and clinical confidence.
- Hardware agnostic, compatible with most major retinal camera brands.
- Provides immediate results, enabling same-visit counseling and reducing follow-up appointments.
- Can be used by non-specialist staff like nurses or technicians with minimal training.
- Demonstrated to be cost-effective and safe for implementation in diabetic eye screening programs.
Limitations
- Screens only for diabetic retinopathy and does not detect other eye diseases.
- Image quality dependency; poor images can lead to ungradable results.
- Lack of public pricing, requiring direct engagement with sales.
- Identified as a screening tool, not a diagnostic device, requiring specialist confirmation for positive results.
- Low real-world usage in the US despite FDA approval, partly due to modest reimbursement rates and high initial costs.
- Some ophthalmologists' dilated exams show higher specificity for ruling out disease.
Based on reviews from: AIToolsBox, Review of Ophthalmology, AI-based DR Screening System Exhibits High Diagnostic Accuracy but Low Usage, UK National Screening Committee Report Singles Out Eyenuk's EyeArt as the Only Diabetic Eye Screening AI Technology Ready for Live Clinical Implementation in the National Health Service, Study Shows Real-World Significance of EyeArt AI Eye Screening System From Eyenuk, Eyenuk, Inc., Ophthalmology Innovation Source, A pilot cost-analysis study comparing AI-based EyeArtu00ae and ophthalmologist assessment of diabetic retinopathy in minority women in Oslo, Norway - PMC, Study Finds Eyenuk Artificial Intelligence Detects Diabetic Retinopathy with Far Greater Sensitivity than Ophthalmologists' Dilated Exams, The Value of Automated Diabetic Retinopathy Screening with the EyeArt System - PMC, Patient and Provider Experience with Artificial Intelligence Screening Technology for Diabetic Retinopathy in a Rural Primary Care Setting - PMC, Ophthalmology - The Physician AI Handbook, AI technologies for detecting diabetic retinopathy | Advice - NICE
Last updated: 2026-07-18
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EyeArtu2122 by Eyenuk, Inc. : Using Artificial Intelligence to screen for Diabetic Retinopathy
