AEYE-DS is an FDA-cleared AI diagnostic screening solution for point-of-care detection of diabetic retinopathy. It is the only FDA-cleared solution that provides instant AI diabetic retinopathy diagnosis using handheld or tabletop retinal cameras. The exam takes just 1 minute and requires only one image per eye with no dilation. Using advanced AI algorithms, AEYE-DS analyzes retinal images and provides an immediate diagnosis at the point of care. The streamlined workflow allows primary care and endocrinology clinics to close HEDIS care gaps, ensure timely follow-up, and provide care, without a specialist over-red.

Yes. AEYE-DS is the first and only fully autonomous AI FDA-cleared technology for use with both tabletop and portable fundus cameras. It is indicated for use by healthcare providers to detect more-than-mild diabetic retinopathy (mtmDR) in adults with diabetes using a single non-mydriatic (retinal image taken without dilation) image per eye.

Practices retain 100% of the reimbursement when billing AEYE-DS under CPT code 92229 because the AI performs the diagnostic analysis autonomously at the point of care. This eliminates the need for specialist over-reads or the professional fee-splitting required by other retinal imaging codes.  CPT 92229 is the dedicated code for point-of-care autonomous retinal analysis, and it is fully reimbursable across Medicare, Medicaid, and private insurance. For 2026, the Medicare national average is approximately $50, while private insurers frequently reimburse up to $100 per exam.

AI-powered retinal screening improve HEDIS scores (Healthcare Effectiveness Data and Information Set) by directly addressing the “Eye Exam for Patients with Diabetes” (EED) measure,the percentage of diabetic patients receiving annual eye exams.Traditionally, this is one of the most difficult care gaps to close because it relies on patients following through with a separate referral to an eye specialist. Using AI-assisted retinal screening can help providers meet or improve HEDIS scores, because it ensures diabetic patients are screened on the spot.

Yes. AEYE‑DS features seamless integration with major electronic medical/health record (EMR/EHR) systems, including Epic. This integration, allows providers to order diabetic retinopathy screenings directly from the patient’s chart.Once the images are captured, AI diagnostic results and reports are returned automatically into the EMR, and can trigger automated referrals within the system if the AI detects referable disease. By consolidating the order, diagnostic report, and documentation within the patient’s medical record and reviewed during the same visit, helping streamline clinical workflow and reduce manual data entry.

Screening with AEYE-DS is designed for seamless integration into routine clinic workflows, typically occurring while the patient is already in the exam or waiting rooms. A provider orders the screening directly from within the patient’s electronic medical record (EMR), and a medical assistant or nurse captures a single retinal image per eye. The autonomous AI analyzes the images in real-time, delivering a diagnostic result directly to the patient’s chart in under a minute. This point of care screening solution automates reporting, CPT 92229 billing, and referrals, enabling the patient and provider to discuss the results and next steps within the same visit. By closing care gaps on the spot, AEYE-DS ensures immediate compliance without disrupting clinical flow.

Point-of-care screening with AEYE-DS allows clinics to provide an instant, autonomous diagnosis for diabetic retinopathy (DR) during the patient visit, eliminating delays from remote specialist review. With just a single, non-dilated image per eye, the screening integrates seamlessly into routine visits, ensuring 100% patient compliance to the annual diabetic eye exam and enabling providers to discuss results and next steps immediately. This approach helps close HEDIS diabetes care gaps, supports timely follow-up, generates reimbursement through CPT 92229, and works with both handheld and tabletop retinal cameras, making it efficient, flexible, and clinically impactful.

No. AEYE-DS screening does not require pupil dilation. The eye exam is designed to be performed quickly at the point of care using a non-mydriatic retinal camera (a camera that does not require dilation) using just one image per eye. If the images captured are not of sufficient quality, images can be retaken on the spot as the AI provides instant analysis and feedback.

Yes, AEYE-DS is compatible and can be used with portable retinal cameras. In fact, AEYE-DS is the first and only FDA-cleared autonomous AI solution for diabetic retinopathy screening that is approved for use with a portable retinal camera, enabling diabetic retinopathy screening to be performed at any point of care.

No. AEYE-DS does not require a specialist to over-read. As a fully autonomous AI diagnostic system, it is FDA-cleared to provide a diagnostic result and report on the spot in under one minute without the need for an ophthalmologist's over-read or remote physician interpretation.Point of care screening with AEYE-DS allows the primary care provider to discuss the diagnosis and next steps during the same patient visit.

The entire AEYE-DS screening process - including image capture and AI analysis, typically takes one minute. Because the system is fully autonomous and requires only a single, non-dilated image per eye, clinic staff can capture the images and receive an an "on-the-spot" diagnostic result (e.g., "More-than-mild (Referable) DR Detected" or "No Referable DR Detected"). This rapid turnaround allows the provider and patient to discuss the results and any necessary referrals during the same encounter, ensuring the screening fits seamlessly into the existing clinical workflow without extending the patient's visit or requiring a follow-up appointment.

AEYE-DS is the first FDA-cleared autonomous AI for diabetic retinopathy to demonstrate high diagnostic performance using a single image per eye. In Phase III pivotal studies, AEYE-DS achieved a sensitivity of 92-93% and a specificity of 89-94% in use with a portable handheld camera and a robotic tabletop camera. Notably, the system maintained a success rate (imageability) of over 99%, ensuring nearly all patients receive a diagnostic result at the point of care.

Traditional teleretinal screening sends retinal images to a remote specialist, often causing 24-72 hour delays and requiring staff to track reports and follow up with patients, which lowers adherence. In contrast, AEYE-DS delivers an autonomous AI diagnosis at the point of care in under one minute using a single, non-dilated image per eye, allowing providers to review results with patients immediately, close HEDIS care gaps, and support timely referrals. Unlike traditional workflows using CPT 92227 or 92228, AEYE-DS uses CPT 92229, offering higher reimbursement without a specialist over-read.

AEYE-X is an AI comprehensive screening technology that analyzes retinal images to detect or predict a broad range of health conditions. By examining images of the retina, the system can identify signs associated with eye diseases such as glaucoma, age-related macular degeneration, cataracts, and diabetic macular edema, as well as potential indicators of systemic conditions like cardiovascular disease, hypertension, and diabetes. The accuracy of disease detection or prediction is backed by studies on large data sets, and supported by extensive statistical analyses

AEYE-DS has a 99% imageability rate, as demonstrated in clinical research, enabling nearly all patients to receive a diagnostic result in a single, non-dilated retinal screening.

AEYE Health provides complementary on-site training for physicians who purchase AEYE-DS. The system can be fully implemented in a clinic within one day, including staff training, device setup, and integration into existing workflows, allowing your team to start capturing retinal images and generating results almost immediately.

AEYE-DS utilizes an all-inclusive Software as a Service (SaaS) model that requires no upfront capital investment. Unlike traditional diagnostic solutions that require a large initial purchase, our model covers all operational costs, including the indicated retinal camera, seamless EHR integration, and software updates, with no hidden charges. To ensure a perfect fit for any healthcare organization, we offer two subscription models: Limited: Tailored for practices with specific or predictable patient volumes. Unlimited: Designed for high-volume health systems looking to maximize screening reach without per-patient constraints. By shifting from a heavy capital investment to a predictable subscription, healthcare providers can deploy life-saving AI technology immediately, focusing on patient care and closing care gaps rather than managing high initial costs.

Yes, AEYE-DS is designed to scale across multiple locations. Whether for a single clinic or an enterprise health system (IDN or multi-site practice), AEYE-DS can be deployed at each site with centralized support, training, and reporting. This allows enterprise buyers to maintain consistent screening protocols, workflow integration, and data management across all locations while ensuring the same high imageability and diagnostic accuracy at every site.