AEYE Health
AEYE Health is a US digital health company that markets AEYE-DS, an FDA-cleared fully autonomous AI for diabetic retinopathy screening using a single retinal image per eye, deployed via SaaS subscription into primary care, endocrinology, teleretinal, pharmacy, and rural clinic settings.
- Company typePrivate
- Founded2019
- HeadquartersNew York, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What AEYE Health does
AEYE Health is a US-based digital health company founded in 2019 in New York City that has built AEYE-DS, an FDA-cleared fully autonomous AI diagnostic screening solution for diabetic retinopathy. The technology applies deep learning algorithms to single non-mydriatic retinal fundus images, delivering a diagnostic result in under one minute with AI processing in under five seconds, without requiring specialist over-read or pupil dilation. AEYE-DS is offered in two hardware configurations — Aurora AEYE on the Optomed portable handheld camera (FDA-cleared May 2024, the first fully autonomous AI approved for portable use) and a tabletop configuration on the Topcon NW400/NW500 — and achieves 92-93% sensitivity, 89-94% specificity, and >99% imageability per Phase III pivotal studies.
The company's product portfolio also includes AEYE-X, an investigational platform that analyzes retinal images to detect or predict 100+ systemic and ocular conditions across four diagnostic pillars (chronic ocular disease, systemic health, cognitive health, and vision/refractive assessment); AEYE-X is not sold in the US. A February 2026 BMJ Innovations publication demonstrated that the company's deep learning technology can estimate both systolic and diastolic blood pressure from a single retinal image, validated against 100,000+ UK Biobank images.
AEYE Health operates on an all-inclusive SaaS subscription model with no upfront capital investment, with Limited and Unlimited tiers aligned to predictable-volume practices and high-volume health systems respectively. The solution integrates with Epic and other major EHRs for automated ordering, result delivery, care gap reporting, and billing under CPT 92229 (~$50 Medicare national average / up to $100 from private insurers per exam in 2026), with practices retaining 100% of reimbursement. Go-to-market combines enterprise field sales into health systems and IDNs, inside sales for mid-market primary care and endocrinology clinics, event-driven demand generation at ADA/ACD/FMX conferences, and a channel partnership with Ford Medical for pharmacy distribution. Named customers include UMass Memorial Health and Bethesda Health Clinic.
AEYE Health firmographics
Firmographics- Name
- AEYE Health
- Legal name
- AEYE Health, Inc.
- Website
- https://aeyehealth.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- AEYE Health is a US digital health company that markets AEYE-DS, an FDA-cleared fully autonomous AI for diabetic retinopathy screening using a single retinal image per eye, deployed via SaaS subscription into primary care, endocrinology, teleretinal, pharmacy, and rural clinic settings.
- Ownership category
- akta.pro rank
AEYE Health industry classification
Industry- Product category
- AI Medical Diagnostics
- NAICS
- Diagnostic Imaging Centers (621512)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Retinal Imaging & OCT Systems (OCT/OCTA, Fundus Cameras, Fluorescein/ICG Angiography) (HLAHAJAB)
- akta.pro secondary industries
- Medical Imaging AI (HDAAAEAH), Ocular Imaging & Diagnostic Testing Centers (HLAKAKAN)
Keywords
Where AEYE Health is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
AEYE Health business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure, Supply Chain
Revenue model
- AEYE-DS SaaS Subscription: All-inclusive Software as a Service (SaaS) subscription model requiring no upfront capital investment. The subscription covers the indicated retinal camera, EHR integration, and software updates with no hidden charges. Two subscription tiers: Limited (tailored for practices with specific/predictable patient volumes) and Unlimited (for high-volume health systems maximizing screening reach without per-patient constraints). Revenue is generated through recurring subscription fees billed on a per-encounter or tiered basis, complemented by CPT 92229 reimbursements retained entirely by the practice.
- CPT 92229 Reimbursement: Autonomous AI retinal analysis is billed under CPT 92229, a dedicated point-of-care autonomous retinal analysis code fully reimbursable across Medicare, Medicaid, and private insurance. For 2026, Medicare national average reimbursement is approximately $50 per exam; private insurers frequently reimburse up to $100 per exam. Practices retain 100% of reimbursement when billing AEYE-DS under CPT 92229 because the AI performs the diagnostic analysis autonomously, eliminating the need for specialist over-reads or fee-splitting.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Limited Subscription - for practices with specific or predictable patient volumes |
| Subscription | Multi-year contract | Unlimited Subscription - for high-volume health systems |
| Transaction based/ take rate | Pay-as-you-go | CPT 92229 Reimbursement (per exam) |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
AEYE Health product offering
Product offeringCore offering
AEYE Health develops and sells FDA-cleared autonomous AI software (AEYE-DS) that analyzes retinal fundus images to screen for diabetic retinopathy at the point of care, delivering diagnostic results in under one minute without requiring specialist interpretation. The all-inclusive SaaS subscription bundles the AI software, compatible retinal cameras (portable Optomed Aurora or tabletop Topcon NW400), and EHR/EMR integration, enabling primary care providers, endocrinologists, health systems, and pharmacies to perform reimbursable DR screening (CPT 92229) during routine visits. The investigational AEYE-X platform extends the technology to comprehensive screening for over 100 ocular and systemic conditions from a single retinal image.
Product overview
AEYE Health offers a dual-product portfolio centered on AI-powered retinal imaging diagnostics. AEYE-DS is the FDA-cleared core product for autonomous diabetic retinopathy screening, available in two configurations: portable (Optomed Aurora) and tabletop (Topcon NW400). AEYE-X is an investigational comprehensive screening platform extending the technology to detect and predict over 100 systemic and ocular conditions from retinal images. Both products use deep learning to analyze retinal images, deliver results in under one minute at point of care, and require only one image per eye with no dilation.
Differentiator
Problem solved
Functional benefit
Brands
- AEYE-DS: FDA-cleared autonomous AI diagnostic screening solution for diabetic retinopathy screening using portable and tabletop retinal cameras.
- AEYE-X
- Aurora AEYE
Products and services
- AEYE-DS FDA-cleared fully autonomous AI diagnostic screening solution for point-of-care detection of more-than-mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes. Uses a single non-mydriatic retinal image per eye with no dilation required, available in portable handheld (Optomed Aurora, 92-93% sensitivity, 89-94% specificity) and tabletop (Topcon NW400, 93% sensitivity, 91% specificity) configurations. Delivers diagnostic results in under one minute with AI processing under 5 seconds, achieves >99% imageability, requires no physician interpretation, and is reimbursable under CPT 92229. Integrates with Epic and other EHRs for automated ordering, result delivery, billing, and care gap reporting.
- AEYE-X Investigational AI-based comprehensive screening platform for detecting or predicting over 100 conditions from single retinal images per eye. Analyzes ocular diseases (diabetic retinopathy, glaucoma, AMD, retinal occlusions, cataract, diabetic macular edema), systemic health (cardiovascular disease, hypertension, diabetes, CKD), cognitive health (dementia risk), and vision/refractive assessment using deep learning algorithms. Camera-agnostic, delivers results in under one minute. Includes predictive blood pressure estimation capability validated against the UK Biobank. Not sold in the US; available for investigational use only.
Companies that use AEYE Health
Customer profileNamed customers2 records
Segments5 records
Ideal customer profiles4 records
AEYE Health technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability5 records
Feature6 records
AEYE Health partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- Epic SystemscoreAEYE Health expanded its nationwide integration of AEYE-DS with Epic Systems' electronic medical record platform, enabling healthcare providers to order and receive diabetic retinopathy screening results in under 1 minute directly within their existing Epic clinical workflows. The integration supports automated billing under CPT 92229, care gap reporting, and automated referral triggers for positive cases. This partnership is described as one of the first-ever AI-specific reimbursement integrations in healthcare.
- Ford MedicalcoreAEYE Health partnered with Ford Medical in July 2025 to distribute AI-based retinal imaging screening solutions across US pharmacies. This partnership enables pharmacy-based point-of-care diabetic retinopathy screening, extending AEYE Health's reach into community retail health settings and expanding access to screening for underserved populations.
- Topcon HealthcarecoreAEYE Health partnered with Topcon Healthcare to integrate its autonomous diabetic retinopathy screening AI into the Topcon NW500 fundus camera (announced April 2025). This enables the Topcon NW500 to deliver AEYE-DS's autonomous AI diagnostic results at the point of care, expanding the hardware ecosystem compatible with AEYE-DS.
- OptomedcoreAEYE Health and Optomed partnered to launch Aurora AEYE, the first FDA-cleared portable AI-powered diabetic retinopathy screening solution providing on-the-spot diagnosis. Optomed provides the Aurora handheld retinal camera; AEYE Health provides the autonomous AI diagnostic software. This partnership resulted in the first-ever FDA clearance for a fully autonomous AI for portable diabetic retinopathy screening (May 2024).
Scale indicators8 records
Recent moves6 records
Expansion highlights5 records
AEYE Health competitors and assessment
Company assessmentDirect peers
- Digital Diagnostics: Digital Diagnostics developed IDx-DR, the first FDA-cleared fully autonomous AI for diabetic retinopathy screening. It is the most direct head-to-head competitor to AEYE-DS in US primary care, sharing the autonomous, non-mydriatic, single-image-per-eye workflow and targeting the same CPT 92229 reimbursement code.
- Eyenovia: Eyenovia acquired the EyeArt AI-based diabetic retinopathy screening system, one of the most widely deployed autonomous DR screening platforms globally. EyeArt competes with AEYE-DS for primary care, endocrinology, and teleretinal screening contracts, and Eyenovia's deeper commercial footprint makes it a key benchmark for AEYE's enterprise sales motion.
- Intelligent Retinal Imaging Systems (IRIS): IRIS operates a teleretinal screening service used by health systems and primary care clinics, and integrated AEYE-DS into its platform in 2023. IRIS is both a distribution partner and a competitor whose legacy human-reader workflow is being displaced by autonomous AI, making it a closely comparable teleretinal service peer.
Broad incumbents
- Topcon Healthcare: Topcon is a global ophthalmic device incumbent whose NW400 and NW500 fundus cameras are integrated with AEYE-DS. As a hardware partner, Topcon is a route to market, but it also develops its own screening software ecosystem and Harmony RS (retinal data management), making it both a collaborator and a potential competitor in integrated DR screening.
- Nanox (Zebra Medical Vision): Nanox acquired Zebra Medical Vision, an AI medical imaging company that analyzes radiology images to detect multiple conditions. While focused on radiology rather than retinal screening, Zebra/Nanox is a comparable medical imaging AI platform peer with a similar multi-condition, AI-driven diagnostic ambition to AEYE-X.
- VoxelCloud: VoxelCloud is a medical imaging AI company providing diagnostic AI solutions across ophthalmology, radiology, and pathology. It is comparable to AEYE Health as a medical imaging AI vendor, with overlap in ophthalmic disease detection from imaging data, and serves as a broad-incumbent reference point for AI clinical screening scale-up.
Emerging players
- Optomed: Optomed is the maker of the Aurora handheld retinal camera, which AEYE-DS is integrated with to produce the only FDA-cleared portable autonomous DR screening solution. Optomed also sells its own AI screening software and competes in the portable fundus camera category, making it a strategic partner with overlapping commercial interests.
- RetinAI Medical (Ikerian): RetinAI Medical (now Ikerian) develops AI platforms for retinal image analysis covering diabetic retinopathy, AMD, and glaucoma, with both pharma research and clinical screening use cases. It is an emerging peer to AEYE-X's multi-condition screening thesis and competes in the broader ophthalmic AI analytics category.
- Sight Diagnostics: Sight Diagnostics applies computer vision and AI to blood and retinal analysis, with FDA-cleared products for point-of-care diagnostics. Its combination of AI imaging diagnostics and decentralised point-of-care deployment is conceptually similar to AEYE's portable, single-image autonomous screening model.
Others
- Arterys: Arterys (now Tempus) provides cloud-native AI medical imaging platforms deployed in clinical workflows. It is an adjacent AI imaging infrastructure peer rather than a direct competitor, but is relevant context for AEYE's positioning of AI diagnostics integrated directly into clinical workflow and reporting.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
AEYE Health social profiles
Digital presenceAEYE Health compliance and trust
Trust signalCompliance1 record
AEYE Health financial estimates
Financial estimateRevenue estimate
Valuation estimate
AEYE Health leadership team
Management profileNumber of profiles
Profiles11 records
AEYE Health funding detail
Funding detailFunding overview
Funding rounds2 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AEYE Health M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about AEYE Health
What does AEYE Health do?
AEYE Health develops and sells FDA-cleared autonomous AI software (AEYE-DS) that analyzes retinal fundus images to screen for diabetic retinopathy at the point of care, delivering diagnostic results in under one minute without requiring specialist interpretation. The all-inclusive SaaS subscription bundles the AI software, compatible retinal cameras (portable Optomed Aurora or tabletop Topcon NW400), and EHR/EMR integration, enabling primary care providers, endocrinologists, health systems, and pharmacies to perform reimbursable DR screening (CPT 92229) during routine visits. The investigational AEYE-X platform extends the technology to comprehensive screening for over 100 ocular and systemic conditions from a single retinal image.
Is AEYE Health a public or private company?
AEYE Health is a private company. It is classified as venture growth investor backed and is currently operating.
When was AEYE Health founded?
AEYE Health was founded in 2019. It employs 11 to 50 people.
Where is AEYE Health based?
AEYE Health is headquartered in New York, United States, in the North America region.
How does AEYE Health make money?
Two revenue lines are on record. AEYE-DS SaaS Subscription is the primary driver. The others are CPT 92229 Reimbursement.
Who are AEYE Health's main competitors?
Direct peers on record are Digital Diagnostics, Eyenovia and Intelligent Retinal Imaging Systems (IRIS). Broad incumbents are Topcon Healthcare, Nanox (Zebra Medical Vision) and VoxelCloud. Emerging players are Optomed, RetinAI Medical (Ikerian) and Sight Diagnostics. Arterys is listed as an others.
Does AEYE Health have an API?
Yes. AEYE-DS features API integration to send exams and receive results, enabling teleretinal screening services to process exams programmatically. The API is scalable to process any volume of exams needed.
What industry is AEYE Health in?
AEYE Health's product category is AI Medical Diagnostics. Its primary akta.pro industry code is HLAHAJAB, Retinal Imaging & OCT Systems (OCT/OCTA, Fundus Cameras, Fluorescein/ICG Angiography), with a secondary code of HDAAAEAH, Medical Imaging AI. Its NAICS code is 621512 and its SIC code is 3841.