AEYE-DS with Portable Camera (Aurora AEYE)
First FDA-cleared, AI-powered diabetic retinopathy solution for portable cameras
Company profile
Company profile
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
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Embedded · Other deployment with recorded integration context.
Company milestones
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
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
First FDA-cleared, AI-powered diabetic retinopathy solution for portable cameras
FDA-cleared autonomous AI diabetic retinopathy screening with robotic desktop cameras
AI-based diagnostic screening for broad range of diseases using retinal images
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
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Research
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
NCT06241664 · Sponsor · COMPLETED
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic ImagesNCT05857943 · Sponsor · COMPLETED
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus ImagesNCT04612868 · Sponsor · COMPLETED
Regulatory
K240058 · 510k · Apr 23, 2024
AEYE-DSK221183 · 510k · Nov 10, 2022
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Success rate for both portable and desktop camera systems
Autonomous AI exam requiring only 1 image per eye
Diabetic retinopathy detection with portable camera
Diabetic retinopathy detection with tabletop camera
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
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 profiles and professional links from the current Company record.
06 · Company updates
Recent articles published on AEYE Health's official website.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
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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