AEYE Health

New York City, NY, USA (1501 Broadway, 12th Floor, New York, NY 10036)  All United States companies → Founded 2018
Imaging AI Specialist Point-of-Care Diagnostics Specialty-Focused AI
Endocrinology Internal Medicine Ophthalmology
Ophthalmology AI
Venture Capital-Backed, with rounds including Seed, Series B, Series C, and recent Equity Crowdfunding; currently generating revenue. — $28.3M

Products

AEYE-DS
AEYE Health
Ophthalmology AI
AEYE-DS is an FDA-cleared, fully autonomous AI diagnostic screening solution from AEYE Health for the point-of-care detection of more-than-mild diabetic retinopathy, providing instant results with no physician interpretation needed.

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About AEYE Health

AEYE Health is a digital health company specializing in FDA-cleared, autonomous AI-based diagnostic screening solutions for retinal imaging. Their flagship product, AEYE-DS, enables healthcare providers, including primary care physicians and endocrinologists, to perform on-the-spot screenings for more-than-mild diabetic retinopathy (DR) in adults with diabetes. This eliminates the traditional need for immediate specialist referrals, making critical sight-saving screenings more accessible, especially in underserved areas. The screening process is efficient, typically taking one minute with a single image per eye, and can be conducted using portable handheld or robotic tabletop cameras, often without pupil dilation.

The AEYE-DS system is designed to seamlessly integrate into existing clinical workflows, providing instant diagnostic reports and supporting improved HEDIS scores and patient outcomes. It is reimbursable under CPT code 92229, offering a practical and financially viable solution for point-of-care screening. Beyond diabetic retinopathy, AEYE Health is actively expanding its comprehensive screening platform to diagnose and predict a broader spectrum of ocular diseases, such as glaucoma, age-related macular degeneration (AMD), diabetic macular edema (DME), occlusions, hypertensive retinopathy, and papilledema. The company is also developing capabilities to detect systemic conditions like hypertension, cardiovascular risk, and dementia from retinal images, aiming for early intervention and prevention of serious health issues.

Focus Areas

Diabetic Retinopathy Retinal Imaging Autonomous AI Diagnostics Point-of-Care Screening Glaucoma Age-related Macular Degeneration (AMD) Hypertension Cardiovascular Risk Dementia

Business Intelligence

Key InvestorsBioLight Life Sciences, OurCrowd, Ambit Health Ventures, SK Group Israel, Sean Ianchulev (Angel), Club 100 Plus, Naska Medical
PartnershipsFord Medical, UMass Medical School, UMass Memorial Health Care, IRIS (Intelligent Retinal Imaging Systems), Topcon Healthcare, Epic EMR
AcquisitionsNone
TechnologyCloud-native, fully autonomous AI-based diagnostic screening solution for retinal imaging, utilizing machine learning algorithms for instant, on-the-spot analysis. Designed for use with both portable handheld and robotic tabletop cameras, requiring only one image per eye and often no dilation. Integrates with Electronic Medical Record (EMR) systems like Epic.
FDA Clearances2 cleared products (estimated)

What Physicians Need to Know

Diabetic Retinopathy (DR) Screening
AEYE Health's AEYE-DS is an FDA-cleared, fully autonomous AI diagnostic screening solution for detecting more-than-mild diabetic retinopathy. It requires only one image per eye, rarely needs dilation, and provides diagnostic results in under one minute at the point of care. The system boasts high accuracy with 92-93% sensitivity and 89-94% specificity, and an imageability rate of over 99%. It is reimbursable under CPT code 92229, specifically for AI diabetic retinopathy screening, and helps close HEDIS care gaps.
Retinal Imaging Technology
The AEYE-DS solution is compatible with both portable handheld cameras (Optomed Aurora) and robotic tabletop cameras (Topcon NW-400), making screening flexible and accessible in various clinical settings. It is the first and only FDA-cleared autonomous AI for DR approved for use with a portable retinal camera.
Autonomous AI Diagnostics
AEYE Health's AI provides fully autonomous diagnostic screening, meaning no physician interpretation is needed for the initial DR screening. The AI analyzes retinal images in real-time, delivering an instant diagnosis directly to the patient's medical record. This capability distinguishes it from other AI solutions that may only offer measurements or decision support.
Point-of-Care Screening
The technology enables on-the-spot screening for diabetic retinopathy in primary care settings, endocrinology clinics, diabetes centers, and even pharmacies, eliminating delays from remote specialist review. This approach significantly improves patient adherence to annual eye exams and allows for immediate discussion of results and next steps with patients.
Comprehensive Retinal Screening (Investigational)
Beyond DR, AEYE Health is developing AEYE Comprehensive Screening (AEYE-CS), which utilizes AI to diagnose or predict a broad range of ocular and systemic conditions from retinal images. These include glaucoma, Age-related Macular Degeneration (AMD), diabetic macular edema (DME), occlusions, hypertensive retinopathy, papilledema, diabetes, cardiovascular diseases, hypertension, and dementia (alpha). Note: AEYE-CS is currently for investigational use only and not sold in the US.
Physician Tip

AEYE Health's solutions offer significant advantages for physicians, particularly in primary care. The autonomous AI for diabetic retinopathy (AEYE-DS) allows for rapid, accurate, and reimbursable point-of-care screening, reducing the administrative burden and eliminating the need for immediate specialist referrals for initial diagnosis. This streamlines clinical workflows, improves HEDIS scores, and enhances patient adherence to critical screenings, leading to earlier detection and intervention for DR. The ability to provide immediate results and discuss them with patients during the same visit fosters better patient education and engagement. For broader disease detection, their investigational AEYE-CS platform aims to provide early insights into a range of ocular and systemic conditions, potentially enabling proactive management and improved patient outcomes across multiple health domains.

AEYE Health's AEYE-DS features seamless integration with major electronic medical/health record (EMR/EHR) systems, including Epic. This integration allows healthcare providers to order diabetic retinopathy screenings directly from the patient's chart, and the AI diagnostic results and reports are automatically returned to the EMR within seconds. The system can also trigger automated referrals to ophthalmology if referable disease is detected, further streamlining care coordination and reducing manual data entry.

Products by AEYE Health

1 product in the directory

AEYE-DS
AEYE Health
Ophthalmology AI
AEYE-DS is an FDA-cleared, fully autonomous AI diagnostic screening solution from AEYE Health for the point-of-care detection of more-than-mild diabetic retinopathy, providing instant results with no physician interpretation needed.

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Press & Coverage

Optometry Times
AEYE Health receives FDA clearance for first ever fully autonomous AI for portable DR screening
AEYE Health has received FDA clearance for its fully autonomous AI to diagnose referable diabetic retinopathy (DR) from retinal images taken by a handheld camera, making it suitable for point-of-care screening. The technology boasts high diagnostic sensitivity and specificity, with almost 100% of patients receiving a diagnostic result from a single image per eye.
2024-05
PR Newswire
AEYE Health's AI Retinal Imaging Redefines Non-Invasive Blood Pressure Monitoring
AEYE Health announced the publication of a study in BMJ Innovations demonstrating that its deep learning technology can estimate systolic and diastolic blood pressure from a single non-mydriatic fundus image with accuracy comparable to traditional arm cuff measurements. This research highlights the retina as a comprehensive and stable indicator of chronic health, offering a paradigm shift in cardiovascular health monitoring.
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 electronic medical record (EMR) platform, across the US healthcare system. This integration facilitates the use of AEYE Health's portable, fully autonomous AI eye screening technology for diabetic retinopathy.
2026-01
Eyes On Eyecare
AEYE Health broadens Epic EMR integration for AI eye screening
AEYE Health has expanded its integration of portable AI-based eye screening technology with Epic, a major US electronic medical record platform. The AEYE-DS system, cleared by the FDA in 2022 and 2024, provides rapid and accurate detection of more-than-mild diabetic retinopathy.
2026-02
OurCrowd
AEYE Health and Ford Medical partner to bring fully autonomous, reimbursable AI diabetic eye exam screening solutions to pharmacies
AEYE Health has partnered with Ford Medical to distribute its fully autonomous diabetic eye exam screening solutions to pharmacies and non-acute centers nationwide. This collaboration aims to make early detection of diabetic retinopathy more accessible and is fully reimbursable under an existing CPT code.
2025-07
Ophthalmology Times
AEYE Health gains FDA clearance to screen diabetics to head off blindness | Eye Care Network - Ophthalmology Times
AEYE Health received FDA clearance to market its screening system for detecting retinal damage in diabetics, with the company noting that screening for retinopathy has recently become reimbursable in the US. The technology uses a desktop camera and AI to analyze retinal data for disease diagnosis.
2022-11
BMJ Innovations (via AEYE Health Publications)
Non-contact optical blood pressure biometry using AI-based analysis of non-mydriatic fundus imaging
This peer-reviewed article details research on using AI-based analysis of non-mydriatic fundus imaging for non-contact optical blood pressure biometry. It highlights AEYE Health's work in leveraging retinal images for broader health insights beyond just eye diseases.
unknown
Tracxn
AEYE Health - 2026 Funding Rounds & List of Investors - Tracxn
AEYE Health has raised a total of $1 million in one seed funding round, with Florida-Israel Business Accelerator as its sole institutional investor.
2026-05

Frequently Asked Questions

AEYE Health's primary offering is AEYE-DS, a fully autonomous, AI-based diagnostic screening solution for diabetic retinopathy. It uses a single retinal image per eye to provide an on-the-spot diagnostic report in under a minute, without requiring physician interpretation. This solution is FDA-cleared for detecting more-than-mild diabetic retinopathy and is reimbursable under CPT code 92229, aiming to make screening practical and accessible at the point of care.
While AEYE-DS is FDA-cleared for diabetic retinopathy, AEYE Health also offers AEYE Comprehensive Screening (AEYE-X), which is designed to screen for a broader range of conditions including glaucoma, age-related macular degeneration (AMD), cataracts, and diabetic macular edema. Furthermore, AEYE-X utilizes retinal images to detect or predict systemic diseases like cardiovascular disease, hypertension, and diabetes, and research indicates its potential for non-invasive blood pressure monitoring and insights into cardiovascular risk and dementia concerns. Note that AEYE-X is currently for investigational use only in the US.
AEYE Health's AEYE-DS system has received FDA clearance as the first fully autonomous AI for portable diabetic retinopathy screening, demonstrating high diagnostic sensitivity (92-93%) and specificity (89-94%) in large-scale prospective Phase 3 studies. The system operates autonomously, providing results without the need for human interpretation, and is compliant with CPT code 92229 for reimbursement, which is specifically for autonomous retinal analysis.
Integrating AEYE Health's point-of-care screening allows for a one-minute exam using a single image per eye, which can be performed by any healthcare professional without requiring pupil dilation. The system provides immediate diagnostic results, enabling on-the-spot patient discussions and timely referrals, thereby closing care gaps and improving patient adherence. It also offers seamless integration with major EMR platforms like Epic, automating exam orders, result delivery, and CPT 92229 billing.
AEYE Health operates on an all-inclusive Software as a Service (SaaS) model for AEYE-DS, eliminating the need for upfront capital investment. This model covers all operational costs, including the indicated retinal camera, seamless EHR integration, and software updates. Practices retain 100% of the reimbursement when billing under CPT code 92229, which is typically higher than other retinal imaging codes. AEYE Health also provides complementary on-site training for implementation, which can be completed within one day.
AEYE Health has established strategic partnerships with key players in the healthcare technology sector, including camera manufacturers like Optomed and Topcon, and EMR providers such as Epic for seamless integration. They also partner with distributors like Ford Medical to expand reach into pharmacies and non-acute care settings, and with IRIS for AI screening. The company is venture-backed, having raised $28.3 million, and is experiencing rapid nationwide expansion, indicating strong growth and stability.

Investors

Who's funded AEYE Health.

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