Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryAEYE-DS medical AI product profile
FDA-cleared autonomous AI diagnostic screening system for more-than-mild diabetic retinopathy in eligible adults with diabetes.
Medical imaging and radiology
Best fit
Clinics that want same-visit diabetic retinopathy screening with supported cameras, trained image capture, EHR reporting, and defined referral routing.
- Primary use case
- Autonomous point-of-care diabetic retinopathy screening from tabletop or portable non-mydriatic fundus-camera images
- Audience
- Primary care groups, endocrinology clinics, diabetes programs, payers, and health systems closing diabetic eye-exam gaps
- Risk level
- High
- Pricing signal
- Provider deployment pricing; verify camera bundle, EHR integration, CPT 92229 billing assumptions, and current payer reimbursement.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating AEYE-DS as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match deployment to the current AEYE-DS 510(k), camera, indication, contraindications, trained-user workflow, eligible adult diabetes population, and local diagnostic-screening rules. |
|---|---|
| Privacy | Review retinal-image capture, identifiers, EHR ordering and result return, de-identified model-improvement use, U.S. hosting, retention by provider agreement, access controls, and BAA or data-processing terms. |
| Evidence | Validate local performance against the clinic's camera, operator skill, image-quality rate, patient demographics, disease prevalence, follow-up capacity, and expectations for non-diabetic eye disease. |
| Workflow | Best governed as a protocolized care-gap closure workflow with eligibility checks, trained capture, report review, referral routing, billing review, and quality monitoring. |
Where AEYE-DS fits
AEYE Health describes AEYE-DS as an FDA-cleared autonomous diabetic-retinopathy screening system for one non-mydriatic image per eye using supported Topcon NW400 and Optomed Aurora cameras; FDA records list AEYE-DS K221183 and K240058, and AEYE privacy materials describe retinal-image, exam-identifier, MRN, and diagnostic-result processing.
Not for: Comprehensive eye exams, glaucoma or other ocular-disease screening, use outside eligible adult diabetes populations, or workflows without referral capacity.
What to verify before using AEYE-DS
- Current FDA 510(k) record, supported camera model, software version, indication, contraindications, and adult diabetes eligibility rules.
- Image-capture workflow, operator training, unreadable-image handling, repeat-test rules, and same-day referral instructions.
- How retinal images, identifiers, diagnostic results, EHR orders, reports, de-identified data use, and retention are governed.
- Local monitoring for unreadable exams, false positives, false negatives, non-DR eye disease expectations, follow-up completion, and equity.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.aeyehealth.com / aeye-diagnostic-screening
- www.aeyehealth.com / privacy-policy
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / pdf24
Related medical AI products
Medical imaging and radiology
Viz.ai
AI-powered care coordination platform with imaging-driven alerts across therapeutic areas.
Medical imaging and radiology
Ferrum Health
Clinical AI governance and deployment platform for health systems adopting multiple imaging or clinical AI models.
Medical imaging and radiology
Blackford Platform
Enterprise medical imaging AI platform for evaluating, deploying, routing, and monitoring multiple radiology AI applications.