Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryRETINA-AI Galaxy medical AI product profile
FDA-cleared autonomous diabetic retinopathy screening software for moderate-or-worse diabetic retinopathy using supported robotic fundus cameras.
Medical imaging and radiology
Best fit
Primary-care and payer workflows that need fast same-visit diabetic retinopathy screening across supported camera options.
- Primary use case
- Autonomous detection of moderate-or-worse diabetic retinopathy from supported retinal fundus cameras in primary care settings
- Audience
- Primary care clinics, payer care-gap programs, diabetes programs, and health systems evaluating multi-camera diabetic retinopathy screening
- Risk level
- High
- Pricing signal
- Commercial pricing varies by camera, service model, and care-gap workflow; verify current contract and reimbursement assumptions.
- Official sources
- 3 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 RETINA-AI Galaxy as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Use only within the current FDA-cleared indication, camera list, adult diabetes population, contraindications, warnings, and physician-review workflow. |
|---|---|
| Privacy | Request current HIPAA audit evidence, BAA terms, image and report retention, support access controls, EHR export details, and any secondary-use or model-improvement terms. |
| Evidence | Review pivotal-study results and run local monitoring by camera, operator, image quality, dilation rate, disease prevalence, false-negative risk, and referral follow-through. |
| Workflow | Best governed as autonomous screening that still requires physician review of results, patient instructions, retest or referral rules, and follow-up tracking. |
Where RETINA-AI Galaxy fits
RETINA-AI states that Galaxy is FDA-cleared for autonomous detection of moderate-or-worse diabetic retinopathy and lists indications, supported CenterVue DRSPlus, Crystalvue NFC-700, and Topcon NW400 cameras, contraindications, warnings, and HIPAA compliance claims.
Not for: Comprehensive eye disease detection, patients outside the indicated diabetes population, unsupported cameras, or settings without physician review and referral instructions.
What to verify before using RETINA-AI Galaxy
- FDA-cleared indication, compatible cameras, contraindications, warnings, and patient eligibility before purchase.
- Whether the workflow screens for moderate-or-worse diabetic retinopathy only and how patients are warned about non-DR eye disease limits.
- How images, patient identifiers, reports, EHR export, support access, retention, and HIPAA controls are handled.
- Local performance for image quality, dilation needs, false negatives, referral burden, follow-up completion, and camera-specific operator training.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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