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AEYE-DS

by AEYE Health · Based in United States → — Autonomous Diagnostic Screening for Diabetic Retinopathy

Endocrinology Internal Medicine Ophthalmology

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Overview

AEYE-DS by AEYE Health is an FDA-cleared, fully autonomous artificial intelligence (AI) diagnostic screening solution designed for the point-of-care detection of more-than-mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.

The system utilizes advanced AI algorithms to analyze retinal images, providing an immediate diagnosis in under one minute, directly at the point of care. It is compatible with both tabletop (Topcon NW400) and portable handheld (Optomed Aurora) retinal cameras, making screenings accessible in various settings including primary care, endocrinology clinics, and even pharmacies.

AEYE-DS is unique in its ability to provide a diagnostic result and report on the spot without the need for specialist over-reads or physician interpretation, streamlining clinical workflows and enabling primary care providers to discuss results and next steps during the same patient visit. The solution supports CPT code 92229 for autonomous retinal analysis, which is fully reimbursable across Medicare, Medicaid, and private insurance, helping clinics close HEDIS care gaps and improve quality scores.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

1-minute autonomous AI DR exam
Single image per eye, no dilation required
On-the-spot diagnostic report
No physician interpretation needed
CPT 92229 reimbursable
Closes HEDIS care gaps and improves quality scores
Compatible with portable handheld and tabletop retinal cameras (Topcon NW400, Optomed Aurora)
High diagnostic accuracy (92-93% sensitivity, 89-94% specificity)
Over 99% imageability rate
EMR integration (e.g., Epic)

Use Cases

Point-of-care diabetic retinopathy screening in primary care
Diabetic retinopathy screening in endocrinology clinics
Diabetic retinopathy screening in pharmacies and non-acute centers
Closing HEDIS care gaps for diabetic eye exams
Reducing specialist referrals for initial DR screening
Early detection and prevention of vision loss due to DR

What Physicians Need to Know

Retinal Image Analysis

AEYE-DS primarily analyzes fundus images, requiring only one image per eye. It is compatible with desktop cameras like the Topcon NW400 and portable cameras such as the Optomed Aurora.

Diabetic Retinopathy Screening Accuracy

In FDA clinical studies for detecting more-than-mild diabetic retinopathy (mtmDR), AEYE-DS demonstrated a sensitivity range of 92-93% and a specificity range of 89-94% when used with the Optomed Aurora camera. With the Topcon NW400, it showed 93% sensitivity and over 91% specificity.

Glaucoma Detection

While AEYE-DS is specifically for diabetic retinopathy, AEYE Health has a follow-on program for glaucomatous optic neuropathy screening, which has shown high diagnostic potential (92.2% sensitivity and 92.6% specificity) in early research, with FDA pivotal trials anticipated.

Age-Related Macular Degeneration Screening

AEYE-DS is not indicated for Age-Related Macular Degeneration (AMD) screening. However, AEYE Health's broader 'AEYE Comprehensive Screening' (AEYE-CS), which is for investigational use only, includes AMD detection.

Autonomous vs Assistive Diagnosis

AEYE-DS is a fully autonomous AI system, providing diagnostic results for more-than-mild diabetic retinopathy without requiring physician interpretation.

Point-of-Care Deployment

Designed for practical point-of-care screening, AEYE-DS delivers diagnostic reports within minutes using a single image per eye and can be operated by various healthcare professionals.

Screening Program Integration

AEYE-DS integrates with Electronic Medical Record (EMR) systems like Epic, enabling seamless ordering of exams, real-time result delivery to patient charts, and automated alerts for ophthalmology follow-up. It is reimbursable under CPT code 92229.

FDA De Novo vs 510(k) Pathway

AEYE-DS received FDA clearance through the 510(k) pathway in late 2022, utilizing IDx-DR (now LumineticsCore) as its predicate device. It also secured FDA clearance in 2024 for use with a portable camera.

Physician Tip

AEYE-DS offers a rapid, autonomous, and highly accurate screening solution for more-than-mild diabetic retinopathy at the point of care. Its integration with EMR systems and CPT reimbursement (92229) streamlines workflow and improves patient adherence to annual screenings. Consider its use in primary care, endocrinology, and diabetes centers to enhance early detection and facilitate timely referrals to ophthalmologists, especially for patients who might otherwise miss crucial eye exams. While AEYE-DS is currently focused on DR, be aware of AEYE Health's ongoing development in glaucoma and AMD screening with their investigational AEYE-CS platform.

AEYE-DS boasts robust integration capabilities, notably with Epic EMR, allowing for direct exam orders from patient charts and automatic return of results. This seamless integration supports automated alerts for follow-up and full automation of reimbursement code billing and care gap reporting, significantly enhancing operational efficiencies and patient management within existing healthcare infrastructures. It is compatible with Topcon NW400 and Optomed Aurora cameras.

At a glance

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Details

Category	Ophthalmology AI
Pricing	Contact for pricing CPT code 92229 reimbursable; Medicare national average approximately $50, private insurers frequently reimburse up to $100 per exam
Deployment	Cloud
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	Yes AI-estimated AEYE-DS received FDA clearance K240058 on April 23, 2024, for the autonomous detection of more-than-mild diabetic retinopathy (mtmDR) in adults with diabetes. It is cleared for use with the Topcon NW400 and Optomed Aurora cameras, including portable handheld devices.
Integrations
EHR	Not specified
Specialties	Endocrinology, Internal Medicine, Ophthalmology

What the Web Says

AEYE-DS is an FDA-cleared, fully autonomous AI diagnostic screening solution for diabetic retinopathy, designed for point-of-care use. It utilizes either portable or tabletop retinal cameras and can provide instant diagnoses with high accuracy, often without the need for pupil dilation. The system aims to streamline diabetic retinopathy screening, improve patient adherence, and close care gaps in primary care settings.

Overall: Positive

Strengths

FDA-cleared for autonomous detection of more-than-mild diabetic retinopathy.
High diagnostic sensitivity (92-93%) and specificity (89-94%).
Uses a single image per eye, rarely requiring dilation, making the process quick and painless (around one minute).
Portable and tabletop camera options allow for flexible point-of-care screening.
Seamless integration with major EHR/EMR systems (e.g., Epic) for automated reporting and billing.
Reimbursable with a dedicated CPT code (92229), offering higher reimbursement without a specialist over-read.

Limitations

Limited information available on AEYE-DS adoption due to recent regulatory clearance compared to competitors.
Requires high-quality images; blurred or poorly illuminated images can impact accuracy.
AI systems are limited in their ability to detect artifacts.
Some general downsides of AI in healthcare include the need for more comprehensive cost-effectiveness studies.
Employee reviews for AEYE Health (the company) mention moderate compensation and limited flexibility in task assignments.

Based on reviews from: AEYE Health Average Salary, Pay Ranges & Benefits, AEYE Health - $4M Raised - Reviews & Alternatives | StartupHub.ai, AEYE Health receives FDA clearance for first ever fully autonomous AI for portable DR screening | Optometry Times - Clinical News & Expert Optometrist Insights, Autonomous Artificial Intelligence in Diabetic Retinopathy Testingu2014Lessons Learned on Successful Health System Adoption - PMC, Advancements in DR Screening Technology - Review of Ophthalmology, AEYE Health: Autonomous Diagnostic Screening, FDA clears first fully autonomous AI for portable diabetic retinopathy screening, AEYE Diagnostic Screening (AEYE-DS) - AEYE Health, AEYE Health reports results of its AI algorithm for autonomous screening and detection of diabetic retinopathy | Eye Care Network - Ophthalmology Times, AI Diagnostic Screening - AEYE Health, AI-based DR Screening System Exhibits High Diagnostic Accuracy but Low Usage, New FDA approval for a diabetic retinopathy screening tool. u2014 Weekly Glance, Financial and Operational Benefits of AI Screening in Primary Care with AEYE-DS, FDA Clears First Fully Autonomous AI for Portable Diabetic Retinopathy Screening

Last updated: 2026-07-21

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Press & Coverage

PR Newswire

AEYE Health's AI Retinal Imaging Redefines Non-Invasive Blood Pressure Monitoring

AEYE Health announced a landmark study in BMJ Innovations demonstrating its deep learning technology can estimate blood pressure from retinal images with accuracy comparable to traditional arm cuff measurements. This research highlights the potential of AEYE-X, AEYE Health's comprehensive AI screening solution, to leverage retinal images for a wide range of medical indications beyond diabetic retinopathy.

2026-02

PR Newswire

AEYE Health Expands Epic Integration for Portable Fully-Autonomous AI Eye Screening Across the US Healthcare System

AEYE Health announced the expanded deployment of its integration with Epic, a widely used EMR platform, enabling healthcare providers to order and receive real-time diabetic retinopathy (DR) screening results in under one minute directly within Epic. This enhanced integration supports portable AI screening and aims to accelerate adoption across hospitals and clinics.

2026-01

Taylor & Francis

Patient Perspectives on Artificial Intelligence-Based Diabetic Retinopathy Screening at an Urban US Medical Center

This study examined patient perspectives on AI-based DR screening using the Aurora AEYE handheld camera with AEYE-DS software, finding that most participants were comfortable with AI as part of the eye exam and satisfied with the screening, though fewer believed it could replace a doctor's visit. The research suggests that patient perspectives on AI-based DR screening may vary by sociodemographic characteristics.

2026-02

PMC (PubMed Central)

Autonomous Artificial Intelligence in Diabetic Retinopathy Testingu2014Lessons Learned on Successful Health System Adoption

This article reviews the adoption of AI-aided DR testing systems, including AEYE-DS, in clinical settings, noting that AEYE-DS received FDA clearance in October 2022 and has been implemented in select community-based health organizations. The study highlights that AEYE-DS requires only one image per eye for diagnosis and rarely requires dilation, distinguishing it from other commercially available systems.

2026-01

Healio

Automated AI diabetic retinopathy screening coming to pharmacies

AEYE Health partnered with Ford Medical to distribute the AEYE-DS system to pharmacies and non-acute centers in the U.S., making fully autonomous diabetic retinopathy screening more accessible. The AI-driven technology works with compatible retinal cameras to provide point-of-care diagnosis for more than mild diabetic retinopathy.

2025-08

Modern Optometry

AEYE Health and Topcon Healthcare Announce Results of Autonomous DR Screening Study

AEYE Health and Topcon Healthcare announced strong results from a study evaluating Topcon's NW500 non-mydriatic retinal camera with AEYE-DS, achieving 92% sensitivity and 90% specificity, and 100% imageability without dilation. AEYE-DS remains the only approved autonomous AI solution requiring a single image per eye, significantly reducing screening time.

2025-02

HCPLive

FDA Authorizes Autonomous AI for Portable Diabetic Retinopathy Screening

The FDA cleared AEYE-DS for portable diabetic retinopathy screening using the Optomed Aurora device, marking the first autonomous AI solution for accessible screening anywhere with a handheld camera. This clearance is based on two large-scale Phase 3 studies showing high diagnostic sensitivity and specificity, and the procedure takes approximately one minute.

2024-04

Optomed

Optomed Aurora with AEYE has received FDA clearance in the US

Optomed announced that its Optomed Aurora handheld fundus camera with AEYE's AI, AEYE-DS, received 510(k) clearance from the FDA, making it the first handheld AI screening solution to obtain such clearance. This is expected to revolutionize patient care and diagnosis of diabetic retinopathy, with results available within 60 seconds.

2024-04

Videos

Product demos, reviews, and walkthroughs for AEYE-DS.

AuroraAEYE one-shot demo video

AEYE-DS with Topcon NW400 - One shot Demo

AEYE Diagnostic Screening

View all on YouTube

Frequently Asked Questions

What is AEYE-DS and how is it used in an ophthalmology setting?

AEYE-DS is an FDA-cleared, fully autonomous AI diagnostic screening solution designed to detect more-than-mild diabetic retinopathy (mtmDR) at the point of care. It is used by healthcare providers, including non-ophthalmic staff, to screen adults with diabetes who have not been previously diagnosed with DR, utilizing compatible retinal cameras like the Topcon NW400 or Optomed Aurora with a single non-dilated image per eye.

What are the regulatory and compliance aspects physicians should be aware of regarding AEYE-DS?

AEYE-DS is FDA-cleared as a Class II medical device, signifying its safety and efficacy for autonomous diabetic retinopathy screening. It helps clinics meet HEDIS care gap requirements and is reimbursable under CPT code 92229, which is specifically for autonomous AI retinal analysis.

Are there alternative AI solutions for diabetic retinopathy screening, and how does AEYE-DS compare?

Yes, other FDA-cleared autonomous AI systems for diabetic retinopathy screening include LumineticsCore (formerly IDx-DR) and EyeArt. AEYE-DS differentiates itself by often requiring only a single non-dilated image per eye and offering high sensitivity and specificity, with over 99% imageability, making it a highly efficient point-of-care solution.

How is AEYE-DS typically priced for clinics, and what are the reimbursement options?

AEYE-DS is offered through subscription models, either limited or unlimited, which cover operational costs including the retinal camera, EHR integration, and software updates, rather than a large upfront capital investment. It is fully reimbursable under CPT code 92229, with Medicare reimbursement averaging around $50 and private insurers often reimbursing up to $100 per exam.

What are the limitations of AEYE-DS that ophthalmologists should consider?

While highly effective for screening, AEYE-DS is specifically indicated for detecting more-than-mild diabetic retinopathy and does not assess the severity of DR, recommend treatment, or detect other ocular conditions like glaucoma or cataracts. It is not a substitute for a comprehensive eye examination or an ophthalmologist's clinical judgment, and it is intended for patients not previously diagnosed with DR.

Does AEYE-DS integrate with existing Electronic Health Record (EHR) systems?

Yes, AEYE-DS offers seamless integration with major EHR systems, including Epic. This integration allows providers to order screenings directly from a patient's chart, and the AI diagnostic results and reports are automatically returned to the EMR, potentially triggering automated referrals for detected disease.

What is the typical workflow for using AEYE-DS in a clinical setting?

The AEYE-DS screening process is designed for efficiency, typically taking about one minute. A healthcare provider orders the screening, a medical assistant or nurse captures a single non-dilated retinal image per eye, and the autonomous AI provides an instant diagnostic result directly to the patient's chart, allowing for immediate discussion of results and next steps.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20