Eyenuk

Woodland Hills, CA, USA All United States companies → — Founded 2010

Imaging AI Specialist Specialty-Focused AI

Endocrinology Family Medicine Ophthalmology

Ophthalmology AI

Series A — $43M

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Products

EyeArt

Eyenuk

Ophthalmology AI

EyeArt is an FDA-cleared AI system by Eyenuk for autonomous detection of diabetic retinopathy, providing rapid, accurate, and on-site screening results in under 60 seconds, enhancing patient care in primary and eye care settings.

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About Eyenuk

Eyenuk, Inc. is a global artificial intelligence (AI) medical technology and services company dedicated to preventing blindness and accelerating the transition to predictive and preventative healthcare. The company specializes in real-world AI Eye Screening™ for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Their mission is to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases.

Their flagship product, the EyeArt® AI Eye Screening System, is designed to make in-clinic, real-time diabetic retinopathy (DR) screening possible for primary care practices, diabetes centers, and optometric offices. The system autonomously analyzes retinal images to detect the presence and extent of lesions, and determines the level of disease based on internationally recognized clinical scales, providing results in under 60 seconds without the need for an eyecare specialist on-site. The EyeArt system is the first and only FDA-cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy, and is also cleared for use with multiple camera models from different manufacturers.

Beyond diabetic retinopathy, Eyenuk is developing a portfolio of AI-based products to address other critical eye and systemic diseases. Their innovation pipeline includes solutions for age-related macular degeneration (AMD), glaucoma, stroke risk, cardiovascular risk, and Alzheimer’s disease, leveraging retinal imaging as a window into overall health. The company aims to expand access to crucial screenings, improve patient compliance, and enable early intervention to save sight and potentially impact the management of other chronic conditions.

Focus Areas

Diabetic Retinopathy Age-related Macular Degeneration Glaucomatous Optic Nerve Damage AI Eye Screening AI Predictive Biomarkers Stroke Risk Cardiovascular Risk Alzheimer's Disease

Business Intelligence

Key Investors	AXA IM Alts, T&W Medical A/S, A&C Foelsgaard Alternativer ApS, Kendall Capital Partners, KOFA Healthcare
Partnerships	Public Health England (PHE)/UK National Health Service (NHS), World Diabetes Foundation, Armenian Eyecare Project, American Academy of Ophthalmology, Vision Loss Rehabilitation Canada, South-Eastern Norway Regional Health Authority (Helse Sør-Øst RHF), MaineHealth Innovation, Meritus Health
Acquisitions	None
Technology	AI-based retinal image analysis, cloud-based analysis, machine learning, autonomous disease detection, AI Predictive Biomarkers, compatible with multiple fundus cameras
FDA Clearances	1 cleared products (estimated)

What Physicians Need to Know

Diabetic Retinopathy (DR)

Eyenuk's flagship EyeArtu00ae AI Eye Screening System provides autonomous detection of more than mild and vision-threatening diabetic retinopathy. It is FDA-cleared and has demonstrated high real-world sensitivity (96% for more than mild DR and 97% for vision-threatening DR) and specificity (88% for more than mild DR and 90% for vision-threatening DR). The system enables immediate, on-site screening and generates reports in under 60 seconds, often without the need for pupil dilation.

Age-related Macular Degeneration (AMD)

The EyeArt system has received CE marking as a Class IIb medical device in the European Union for the autonomous detection of Age-related Macular Degeneration (AMD). This allows for automated screening, grading, and reporting of AMD from a single exam, making screening more accessible.

Glaucomatous Optic Nerve Damage

Eyenuk's EyeArt system also holds CE marking as a Class IIb medical device in the European Union for the autonomous detection of glaucomatous optic nerve damage. This enables automated screening, grading, and reporting for glaucoma at the point-of-care.

AI Eye Screening

Eyenuk is a leader in real-world AI Eye Screeningu2122, offering autonomous disease detection. Their EyeArt system is the world's most-validated AI screening tool, tested on over half a million patient visits globally with over two million images. It integrates deep learning and image analysis algorithms to provide fast, accurate, and consistent results.

AI Predictive Biomarkers

Eyenuk is developing AI Predictive Biomarkersu2122 for risk assessment and disease surveillance. Their EyeMarku2122 product is designed to automatically and accurately track retinopathy progression from visit to visit, providing valuable information beyond a simple positive/negative assessment. They are also researching the use of retinal images for predicting stroke risk, cardiovascular risk, and Alzheimer's disease.

Stroke Risk & Cardiovascular Risk

Eyenuk is actively developing AI Predictive Biomarkers for assessing stroke and cardiovascular risk through retinal image analysis. The eye offers a non-invasive window into the central nervous system and vascular health, allowing for the detection of microvasculature issues that may indicate broader systemic problems.

Alzheimer's Disease

Eyenuk is involved in research, including a National Health Institute-funded study with Mayo Clinic, to explore the potential for predicting Alzheimer's disease through AI analysis of retinal images. They are developing AI Predictive Biomarkers for risk assessment and surveillance of Alzheimer's disease.

Physician Tip

Eyenuk's technology, particularly the EyeArt system, empowers physicians and general practitioners to provide comprehensive diabetes care by enabling in-clinic, real-time eye screenings without needing an on-site eye care specialist. This improves patient compliance with annual screenings, reduces unnecessary referrals, and allows ophthalmologists to focus on higher-yield procedures. The system delivers actionable, easy-to-read, ICD-10 compliant reports quickly, enhancing patient education and potentially improving HEDIS measures and CMS 5-Star quality ratings. Its autonomous nature and high accuracy, even with non-dilated images, make it a valuable tool for early detection and prevention of vision loss, addressing the shortage of eye care providers.

Eyenuk's EyeArt system is designed for seamless integration into clinical workflows. It is compatible with multiple fundus cameras from different manufacturers, including Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400, and Optomed Aurora. The system can also integrate with picture archiving and communications/electronic medical records (PACS/EMR) systems. Eyenuk supports federal efforts to promote interoperable standards for ophthalmic imaging data.

At a glance

Founded 2010

HQ Woodland Hills, CA, USA · United States

Team size 27 as of Jul 01, 2024

CEO Gaurav Agarwal

Funding Series A — $43M

FDA clearances 1 (estimated)

Products 1

Products by Eyenuk

1 product in the directory

EyeArt

Eyenuk

Ophthalmology AI

What the Web Says

Eyenuk is a global artificial intelligence (AI) medical technology company specializing in AI eye screening for diseases like diabetic retinopathy (DR), glaucoma, and age-related macular degeneration (AMD). The company's flagship product, the EyeArt AI Eye Screening System, has received FDA clearance and CE marking for autonomous detection of multiple eye diseases. Reviews highlight its strong diagnostic accuracy and potential to significantly improve access to timely eye screenings, particularly for diabetic retinopathy. While the technology is praised for its clinical effectiveness, challenges exist in widespread adoption due to factors like reimbursement rates and initial integration costs.

Overall: Positive

Strengths

High diagnostic accuracy for detecting referable diabetic retinopathy, with high sensitivity.
Autonomous AI system provides immediate results, reducing the need for ophthalmologist review for initial screening.
Expands access to eye screenings, especially in primary care settings and underserved populations.
Can detect vision-threatening diabetic retinopathy, enabling early intervention.
Validated in numerous real-world studies and a prospective pivotal clinical trial.
FDA-cleared and holds Class IIb MDR CE marking for multiple diseases.

Limitations

Modest reimbursement rates in some regions (e.g., US) hinder widespread adoption.
High initial costs for equipment and IT integration can be a barrier for primary care facilities.
Variability in specificity and inconsistent reporting for ungradable images in some studies.
Lack of detailed information on how ungradable images are processed by the AI system.
Limited public reviews on platforms like G2, Glassdoor, and Capterra specifically for Eyenuk as a company or employer.

Based on reviews from: PR Newswire, Ophthalmology Times, Fierce Healthcare, Vertex AI Search, Reddit

Last updated: 2026-07-18

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Press & Coverage

Eyenuk, Inc.

Eyenuk Secures World's First National Health System Deployment of Autonomous AI Eye Screening Technology

Eyenuk's EyeArt AI Eye Screening System has been selected for deployment in the South-Eastern Norway Regional Health Authority, marking the first national health system to broadly adopt autonomous AI for eye disease detection. This initiative aims to increase timely retinal examinations for people with diabetes from 55% to over 95%.

2025-09

PR Newswire

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system for automatic detection of diabetic retinopathy, expanding its compatibility beyond Canon cameras. This clearance also includes Real-Time Image Quality Feedback and an upgraded image quality assessment module.

2023-06

Eye Care Network (Ophthalmology Times)

Eyenuk receives approval to market AI screening system in EU

Eyenuk's EyeArt AI eye screening system received European Commission (EC) certification as a Class IIb medical device under the EU's Medical Devices Regulation, allowing it to detect diabetic retinopathy, age-related macular degeneration, and glaucomatous optic nerve damage in a single exam.

2023-01

Eyenuk, Inc.

Eyenuk secures $26 Million Series A funding to accelerate global access to AI-powered eye-screening technology

Eyenuk announced a $26 million Series A financing round, bringing its total funding to over $43 million. The funding, led by AXA IM Alts, will be used to expand its AI product platform with additional disease indications and accelerate global commercialization.

2022-10

Eyenuk, Inc.

Study Finds Eyenuk Artificial Intelligence Detects Diabetic Retinopathy with Far Greater Sensitivity than Ophthalmologists' Dilated Exams

A study published in Ophthalmology Science found that Eyenuk's EyeArt AI system is significantly more sensitive in identifying referable diabetic retinopathy than dilated eye exams performed by ophthalmologists and retina specialists. The EyeArt system also provided actionable results for over 97% of eyes, with most not requiring dilation.

2022-09

Eyenuk, Inc.

Eyenuk Announces Publication of Strong EyeArtu00ae Pivotal Clinical Trial Results in JAMA Network Open

Eyenuk announced the publication of strong EyeArt pivotal clinical trial results in JAMA Network Open, demonstrating exceptional accuracy of the EyeArt system in a pre-registered, prospective, multicenter clinical trial.

2021-11

Eyenuk, Inc.

Eyenuk Announces $6.2 Million Financing to Accelerate Adoption of FDA-cleared AI Technology for Detection of Diabetic Retinopathy

Eyenuk completed a $6.2 million financing round led by AXA IM Alts, with participation from existing investors. The funds will be used to accelerate the commercialization of the EyeArt AI System, which received FDA clearance in 2020.

2021-07

Business Wire

Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening

Eyenuk received 510(k) clearance from the U.S. FDA for its EyeArt autonomous AI System for diabetic retinopathy, making it the first FDA-cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.

2020-08

Frequently Asked Questions

What specific eye diseases does Eyenuk's EyeArt system screen for, and what is its current regulatory status for these conditions?

Eyenuk's EyeArt AI Eye Screening System is FDA-cleared in the U.S. for the autonomous detection of both more than mild and vision-threatening Diabetic Retinopathy (DR). In the European Union, EyeArt holds CE marking under MDR Class IIb for the autonomous detection of Diabetic Retinopathy, Age-related Macular Degeneration (AMD), and Glaucomatous Optic Nerve Damage from a single exam.

How does Eyenuk's AI technology, particularly its 'AI Predictive Biomarkers,' contribute to assessing risks for systemic conditions like stroke, cardiovascular disease, and Alzheimer's?

Eyenuk is actively developing AI Predictive Biomarkersu2122 designed for risk assessment and disease surveillance across a multitude of systemic conditions. By analyzing retinal images, the technology aims to provide insights into risks for stroke, cardiovascular conditions, and Alzheimer's disease, with ongoing research including collaborations like an NIH-funded study with Mayo Clinic for Alzheimer's prediction.

What are the regulatory clearances and compliance standards that Eyenuk's EyeArt system adheres to for patient data security and diagnostic accuracy?

The EyeArt system is FDA-cleared in the U.S. and has CE marking in the EU, along with a Health Canada license for Diabetic Retinopathy. It is designed to be compliant with HIPAA and GDPR for patient data privacy and security, and has undergone independent audits for SOC2 Type II and HIPAA compliance.

Can healthcare providers receive reimbursement for using Eyenuk's EyeArt AI Eye Screening system, and what is the general pricing structure?

Yes, the EyeArt AI system is reimbursable by Medicare in the U.S. under the Category 1 Current Procedural Terminology (CPT) code 92229. CMS has established a national payment rate for this code, estimated at approximately $45.69 for the physician fee, though actual amounts may vary by geographic locality. For specific pricing details, Eyenuk encourages direct contact.

What level of support, training, and integration capabilities does Eyenuk offer to healthcare facilities implementing the EyeArt system?

Eyenuk's EyeArt system is designed for ease of use, allowing nurses or technicians to operate it with minimal training. They offer an online web portal for existing users to access support, tutorials, and manuals, with additional assistance available via a contact form. The system also features a RESTful API for seamless integration with existing Electronic Health Record (EHR) and Picture Archival and Communication Systems (PACS).

What is Eyenuk's current market reach and company stability, including its funding and key partnerships?

Eyenuk is a global AI digital health company with its EyeArt system in clinical use across North America, Europe, Africa, India, and Latin America, spanning over 18 countries. The company secured $26 million in Series A funding in October 2022, bringing its total funding to over $43 million, with investors including AXA IM Alts, demonstrating strong financial backing and stability. Eyenuk also engages in strategic partnerships, such as with the American Academy of Ophthalmology for underserved communities and national health systems like Norway's.

How does the EyeArt system enhance clinical workflow and patient care, particularly in primary care settings, for early detection of eye diseases?

The EyeArt system significantly enhances clinical workflow by providing automated, real-time screening for eye diseases like diabetic retinopathy in a single office visit, often without the need for eye dilation. It allows non-specialist staff to capture images and generates easy-to-read reports in under 60 seconds, enabling immediate identification of patients needing specialist referral. This improves patient compliance, reduces costs, and helps close care gaps in primary care.

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