RETINA-AI Health

What RETINA-AI Health does

RETINA-AI Health, Inc. is a Houston-based, privately held healthtech company founded in 2017 that builds artificial intelligence systems to detect eye disease from retinal images. Its flagship product, RETINA-AI Galaxy, is a Software as a Medical Device (SaMD) web application that uses deep learning algorithms trained on images graded by American Board of Ophthalmology-certified retina specialists to autonomously detect moderate or worse Diabetic Retinopathy (mowDRet) in the primary care setting. In a pivotal clinical study, Galaxy demonstrated 90.3% sensitivity and 85% specificity on the CenterVue DRSPlus camera, with sensitivity exceeding 90% for mowDRet and 95% for vision-threatening DR across all three compatible robotic cameras (CenterVue DRSPlus, Crystalvue NFC-700, and Topcon NW400). The product requires no human grader, no on-site eyecare specialist, and produces a diagnostic report in under 10 seconds. It integrates with existing Electronic Health Record systems and runs as a no-install web application on standard browsers.

RETINA-AI Health, Inc. sells Galaxy directly to healthcare providers — primarily primary care physicians, family practices, retail clinics, and pharmacies — with a secondary commercial angle toward insurers and payors. Revenue is generated indirectly through CPT code 92229 Medicare and major healthcare insurance reimbursement for autonomous AI diabetic eye exams performed in primary care settings, with no direct software licensing fee disclosed. The company markets the product as a new revenue stream for PCPs, a tool to close care gaps and improve HEDIS Measures and CMS Star Ratings for payors, and a means to triage diabetic patients at the point of care. RETINA-AI Health, Inc. holds a granted US patent for AI detection of eye disease and maintains ISO 13485:2016, HIPAA, and FDA 21 CFR Part 11 certifications.

The company has raised $8.1 million in total funding across a July 2020 round and a December 2022 bridge financing, with the latter directed at developing RETINA-AI Galaxy v2.0 and supporting the eventual FDA application that produced the 2024 clearance. It operates with 1-10 employees and is led by founder and CEO Dr. Stephen G. Odaibo, a retina specialist who is described as the first ophthalmologist in the world with advanced degrees in both Mathematics and Computer Science. RETINA-AI Health, Inc. has publicly disclosed pipeline plans to extend its AI platform beyond diabetic retinopathy into glaucoma, macular degeneration, cardiovascular risk, and neurological disease detection.

Name

RETINA-AI Health

Legal name

RETINA-AI Health, Inc.

Website

https://retinahealth.ai

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

RETINA-AI Health, Inc. is a Houston-based healthtech company that builds FDA-cleared deep learning AI for autonomous diabetic retinopathy screening in primary care settings, generating revenue via CPT code 92229 reimbursement for PCPs, insurers, and payors.

Ownership category

akta.pro rank

Product category

AI Diagnostic Imaging Software

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Ophthalmic Goods Manufacturing (339115), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), Ophthalmic Goods (3851)

akta.pro primary industry

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)

akta.pro secondary industries

Medical Imaging AI (HDAAAEAH), SaMD – Monitoring, Triage & Risk Stratification Software (HLACANAE)

Keywords

• AI medical imaging
• Diabetic retinopathy detection
• Clinical decision support
• Software as medical device
• Healthcare AI screening

Headquarters

HQ city

Houston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. Healthcare screening reimbursement: RETINA-AI Galaxy generates revenue through Medicare and major healthcare insurance reimbursement via CPT code 92229 for autonomous AI diabetic eye exams. Healthcare providers in primary care settings can bill for the screening service, creating a new revenue stream while closing care gaps and reducing payouts through prevention of blindness.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

RETINA-AI Health develops and sells RETINA-AI Galaxy, a Software as a Medical Device (SaMD) that uses deep learning AI to autonomously detect moderate or worse Diabetic Retinopathy (mowDRet) from retinal images in primary care settings. The web application delivers diagnostic results in under 10 seconds, requires no human grader or on-site eyecare specialist, and is compatible with robotic cameras from three manufacturers (CenterVue DRSPlus, Crystalvue NFC-700, Topcon NW400). The system is FDA cleared, ISO 13485:2016 certified, and HIPAA compliant, and integrates with EHR systems.

Product overview

RETINA-AI Health offers a single unified product: the RETINA-AI Galaxy™ AI system for diabetic retinopathy screening. Galaxy is a Software as a Medical Device (SaMD) web application that uses deep learning to automatically detect moderate or worse Diabetic Retinopathy in primary care settings. The company is also developing pipeline products for glaucoma, macular degeneration, cardiovascular risk, and neurological disease detection. RETINA-AI Galaxy v2.0 is an enhanced version currently undergoing clinical validation.

Differentiator

Problem solved

Functional benefit

Products and services

• RETINA-AI Galaxy Flagship Software as a Medical Device (SaMD) web application that uses deep learning AI to autonomously detect moderate or worse Diabetic Retinopathy (mowDRet) from retinal images in primary care settings. Delivers diagnostic results in under 10 seconds without requiring a human grader or on-site eyecare specialist, integrates with EHR systems, and supports billing via CPT code 92229. Targeted at primary care physicians, healthcare systems, insurers, and payors.
• RETINA-AI Galaxy v2.0 Next-generation version of the RETINA-AI Galaxy AI system for diabetic retinopathy detection, advanced into Phase III clinical trials in November 2022 with planned FDA submission.

Quantifiable outcome

• 90.3% sensitivity and 85% specificity for diabetic retinopathy detection on DRSplus camera
• +4 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability2 records

Feature6 records

Partnerships

Five partnerships are on record, tiered core and minor.

• CenterVuecoreTechnology or IntegrationCenterVue DRSPlus camera is one of three FDA-cleared cameras compatible with RETINA-AI Galaxy for autonomous diabetic retinopathy detection. The DRSPlus is described as a favorite amongst clinic staff and is the highest performing and most technologically advanced option. Partnership enables multi-camera compatibility for different clinical environments.
• CrystalvuecoreTechnology or IntegrationCrystalvue NFC-700 camera is one of three FDA-cleared cameras compatible with RETINA-AI Galaxy. Described as an excellent and cost-effective option for diabetic retinopathy screening in primary care settings.
• TopconcoreTechnology or IntegrationTopcon NW400 camera is one of three FDA-cleared cameras compatible with RETINA-AI Galaxy. Described as a well known and highly available option, making diabetic retinopathy screening accessible in diverse clinical settings.
• Duke UniversityminorStrategic or Co-development PartnerDr. Odaibo serves on the Industry Advisory Board of Duke University's Artificial Intelligence Master of Engineering Program. Team members have backgrounds from Duke University. The company has affiliations with Duke for talent and research.
• Data Science NigeriaminorStrategic or Co-development PartnerDr. Stephen Odaibo serves on the Advisory Board of Data Science Nigeria, supporting AI education and development initiatives in Nigeria.

Scale indicators5 records

Recent moves4 records

Expansion highlights6 records

Direct peers

• Digital Diagnostics: Pioneered the first FDA-cleared autonomous AI for diabetic retinopathy (IDx-DR) and operates in the same autonomous DR screening category, targeting similar PCP and payor customers with a comparable SaMD delivery model.
• Eyenuk: Developer of EyeArt, an FDA-cleared AI for diabetic retinopathy screening used in primary care and retail settings, directly competing with RETINA-AI Galaxy on CPT-92229-style reimbursement and PCPs as the primary buyer.
• AEYE Health: AEYE-DS is an FDA-cleared autonomous AI for diabetic retinopathy screening sold to primary care and retail clinics, competing head-to-head with Galaxy on accuracy, single-visit workflow, and reimbursement-driven economics.
• iHealthScreen: Provides AI-based retinal screening for diabetic retinopathy and AMD risk, targeting primary care and community health settings with an autonomous SaMD approach comparable to RETINA-AI's value proposition.

Broad incumbents

• Verily (Google/Alphabet): Developed an AI system for diabetic retinopathy detection backed by Google's resources and data, competing in the same clinical AI-for-DR space with broader infrastructure, capital, and health system partnerships.
• Aidoc: A well-funded clinical AI platform spanning multiple imaging modalities and use cases. While not DR-specific, Aidoc competes for the same hospital IT, imaging, and AI budget that a PCP-focused DR SaMD would need to displace or complement.
• Arterys: Cloud-based medical imaging AI platform with FDA-cleared models across multiple modalities. Competes for clinical AI mindshare and integration real estate in healthcare systems, adjacent to RETINA-AI's EHR-integrated SaMD approach.

Others

• Topcon Healthcare: One of RETINA-AI's three camera partners (NW400), Topcon is also a broader ophthalmic device and healthcare IT vendor whose own AI/retinal screening initiatives and integrated imaging suites could compete with or complement Galaxy in the same PCP workflow.
• CenterVue (now iCare): Manufacturer of the DRSPlus camera that is part of RETINA-AI's cleared multi-camera footprint. As an iCare-owned entity, it could evolve into a competitor by bundling proprietary AI with its installed base of retinal cameras.

Regional players

• Thirona: EU-based provider of AI-based retinal image analysis (e.g., for DR and COPD), offering a comparable retinal-AI software layer but operating primarily in European markets rather than overlapping directly with RETINA-AI's U.S. PCP channel.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/retina-ai

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RETINA-AI Health