Company profile

AEYE Health

Medical Imaging & Radiology

Company profile

About AEYE Health

AEYE Health is a digital health company founded in 2019 in New York City that develops AI-based autonomous diagnostic screening solutions for ocular and systemic diseases using retinal imaging. The company's flagship product, AEYE-DS, is the only FDA-cleared solution offering instant AI diabetic retinopathy diagnosis with both handheld and tabletop cameras, requiring just one image per eye and delivering on-the-spot diagnostic reports in one minute without physician interpretation needed. The solution is CPT 92229 reimbursable and helps close HEDIS gaps. AEYE Health's technology platform enables screening for a broad range of diseases beyond diabetic retinopathy, including glaucoma, age-related macular degeneration (AMD), diabetic macular edema (DME), and systemic conditions like cardiovascular disease, hypertension, and dementia. Their Aurora AEYE product is the first and only FDA-cleared AI-powered diabetic retinopathy solution for portable cameras, achieving 92-93% sensitivity and 89-94% specificity with over 99% success rate. The company's mission is to make screening for ocular diseases more accessible and help prevent blindness, particularly in underserved communities. By enabling primary care physicians to conduct point-of-care screening, AEYE Health replaces the traditional specialist referral process, addressing the diabetic retinopathy care gap where less than 50% of US patients with diabetes adhere to annual eye exams. The company serves primary care practices, endocrinologists, and teleretinal screening services across the United States.

Company description AEYE Health official website

Primary marketMedical Imaging & Radiology
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Age-related macular degeneration (AMD)
  • Cardiovascular diseases
  • Dementia (alpha)
  • Diabetes
  • Diabetic macular edema (DME)
  • Diabetic retinopathy
  • Glaucoma
  • Hypertension
  • Hypertensive retinopathy
  • Occlusions
  • Papilledema

Who it serves

  • Community health clinics
  • Endocrinologists
  • Health systems
  • Primary care practices
  • Teleretinal screening services

Deployment & integration

Embedded · Other deployment with recorded integration context.

Geographic context

MarketsUnited States
Company sourceOfficial website

Company milestones

Platform expansion

FDA clearance for Aurora AEYE as first and only AI-powered diabetic retinopathy solution for portable camera. Described as 'fastest-growing diabetic retinopathy screening solution in the US'. Participation in major conferences including ADA 2026, ACD 2026, and FMX 2026.

Partnerships

Recorded partners

  • Bethesda Health Clinic
  • UMass Memorial Health

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

AEYE-DS with Portable Camera (Aurora AEYE)

First FDA-cleared, AI-powered diabetic retinopathy solution for portable cameras

Software · EmbeddedCompany source

AEYE-DS with Tabletop Camera

FDA-cleared autonomous AI diabetic retinopathy screening with robotic desktop cameras

Software · EmbeddedCompany source

AEYE-X

AI-based diagnostic screening for broad range of diseases using retinal images

Platform · OtherCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

Evidence position

Publications, clinical validation, and regulatory records connected to this Company appear here.

Research

Publications & preprints

Camera-Agnostic Autonomous Diagnosis of Glaucomatous Optic Neuropathy using Macular Fundus Imaging and Machine Learning.

medRxiv : the preprint server for health sciences · Jan 22, 2026

Remote clinical decision support tool for Parkinson's disease assessment using a novel approach that combines AI and clinical knowledge.

BMC medical informatics and decision making · Aug 7, 2025

Non-Contact Optical Blood Pressure Biometry Using AI-Based Analysis of Non-Mydriatic Fundus Imaging.

medRxiv : the preprint server for health sciences · Jan 7, 2025

Autonomous Screening for Diabetic Macular Edema Using Deep Learning Processing of Retinal Images.

Ophthalmology science · Jan 1, 2025

Diabetes detection from non-diabetic retinopathy fundus images using deep learning methodology.

Heliyon · Aug 30, 2024

Autonomous screening for laser photocoagulation in fundus images using deep learning.

The British journal of ophthalmology · May 21, 2024

Clinical validation

Clinical-trial records

Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images

NCT06241664 · Sponsor · COMPLETED

Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images

NCT05857943 · Sponsor · COMPLETED

Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images

NCT04612868 · Sponsor · COMPLETED

Regulatory

Regulatory records

AEYE-DS

K240058 · 510k · Apr 23, 2024

AEYE-DS

K221183 · 510k · Nov 10, 2022

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

>99% imageability rate

Success rate for both portable and desktop camera systems

1-minute screening time

Autonomous AI exam requiring only 1 image per eye

92-93% sensitivity, 89-94% specificity

Diabetic retinopathy detection with portable camera

93% sensitivity, 91% specificity

Diabetic retinopathy detection with tabletop camera

UMass Memorial Health

Enhanced diabetic eye care adherence with AEYE-DS autonomous screening integrated into EMR system

Integrated AEYE-DS into EMR system for improved diabetic eye care adherence

Bethesda Health Clinic

Provides diabetic retinopathy screenings to uninsured and under-insured populations using AEYE Health AI technology

Enabled accessible diabetic retinopathy screening for underserved populations

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

Pamela F. Gallin

Chief Medical Officer

LinkedIn

Yonatan Raz-Fridman

Chief Business Officer

Aviram Arviv

CFO

Amit Wohl

VP Product & Marketing

Gil Fefer

VP of Engineering

06 · Company updates

Updates from AEYE Health

Recent articles published on AEYE Health's official website.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Medical Imaging & Radiology

Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.

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10 · Pro research

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ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

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