Digital Diagnostics
Digital Diagnostics develops LumineticsCore, the first FDA-cleared autonomous AI system that diagnoses diabetic retinopathy at the point-of-care without physician input. It sells to US health systems, FQHCs, primary care groups, and international partners, reimbursed via CPT code 92229.
- Company typePrivate
- Founded2018
- HeadquartersCoralville, United States
- Headcount101–250
- GTM typeB2B
- OfferingSoftware
What Digital Diagnostics does
Digital Diagnostics is a privately held AI healthcare technology company headquartered in Coralville, Iowa, founded in 2010 (with FDA clearance achieved in 2018), that develops autonomous AI diagnostic systems designed to make clinical diagnoses without physician input. Its flagship product, LumineticsCore (formerly IDx-DR), is an FDA De Novo-cleared deep-learning system that analyzes retinal fundus images (captured via compatible cameras such as the Topcon NW400/NW500) to detect more than mild diabetic retinopathy at the point-of-care, returning a diagnostic result within approximately 30 seconds. The system is supported by SphereDx, a proprietary hosted data platform for diagnostic results management and analytics, and a dedicated training program for clinical operators.
The company's business model centers on per-test reimbursement via CPT code 92229 — the first-ever Category 1 autonomous AI CPT code, established in 2019 with CMS coverage finalized in 2020 — augmented by subscription-based SaaS for SphereDx and negotiated enterprise contracts. Go-to-market relies on direct enterprise field sales to US health systems, hospital networks, FQHCs, and primary care organizations (with named customers including Cleveland Clinic, Stanford Health System, OSF HealthCare, SSM Health, OhioHealth, Banner Health, and University Medical Center), complemented by specialty outreach to ophthalmology and optometry practices, and international distribution via Tamer Group in Saudi Arabia.
Digital Diagnostics serves primary care providers, integrated health systems, FQHCs, payors (Medicare, Medicaid, commercial), and adult diabetic patients, with the core value proposition of closing HEDIS/MIPS care gaps, reducing preventable blindness, and enabling same-visit diabetic eye exams. The company is venture-backed, having raised approximately $75 million in a KKR-led Series B (August 2022) alongside prior rounds, with a board that includes institutional investors (KKR, 8VC, Cedar Pine), strategic health system investors (OSF Ventures, Edward-Elmhurst Health, Gundersen Health System, Optum Ventures), and policy leaders including former US Senate Majority Leader Bill Frist, MD.
Digital Diagnostics firmographics
Firmographics- Name
- Digital Diagnostics
- Legal name
- Digital Diagnostics Inc.
- Website
- https://digitaldiagnostics.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Digital Diagnostics develops LumineticsCore, the first FDA-cleared autonomous AI system that diagnoses diabetic retinopathy at the point-of-care without physician input. It sells to US health systems, FQHCs, primary care groups, and international partners, reimbursed via CPT code 92229.
- Ownership category
- akta.pro rank
Digital Diagnostics industry classification
Industry- Product category
- AI Diagnostic Software / Autonomous Medical Imaging AI
- NAICS
- Medical and Diagnostic Laboratories (62151), Scientific Research and Development Services (5417)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Medical Imaging AI (HDAAAEAH)
- akta.pro secondary industries
- Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK)
Keywords
Where Digital Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Coralville
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Digital Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Others
Revenue model
- Autonomous AI Diagnostic Reimbursement (CPT 92229): LumineticsCore is reimbursable by Medicare, Medicaid, and commercial payers using CPT code 92229, the first-ever autonomous AI Category 1 CPT code established in 2019. This enables sustainable per-test revenue from health systems and provider organizations deploying the AI diagnostic system at point-of-care.
- Enterprise Software/SaaS (SphereDx): SphereDx platform hosts diagnostic patient results and provides analytics capabilities for health system customers using LumineticsCore, representing a potential software/SaaS revenue stream supporting the core diagnostic platform.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Usage-based | Pay-as-you-go | CPT Code 92229 Reimbursement |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels7 records
Digital Diagnostics product offering
Product offeringCore offering
Digital Diagnostics develops and sells LumineticsCore, the first FDA De Novo-cleared autonomous AI diagnostic system that detects more than mild diabetic retinopathy at the point-of-care without physician input, delivering results within 30 seconds of image submission. The platform is supported by SphereDx, a secure hosted platform for diagnostic results and analytics, and is reimbursable via CPT code 92229, enabling health systems to perform diagnostic-grade diabetic eye exams in primary care settings.
Product overview
Digital Diagnostics offers a focused portfolio of AI-powered diagnostic products centered on its flagship autonomous AI platform. The core offering is LumineticsCore®, an FDA-cleared system that autonomously diagnoses diabetic retinopathy without physician input. This is supported by SphereDx™, a secure data platform for hosting and managing diagnostic results, and Luminetics™ Product Line Training for staff education. The products work together as an integrated ecosystem: LumineticsCore performs the diagnostic analysis, SphereDx stores and manages the results and analytics, and the training program ensures proper clinical deployment.
Differentiator
Problem solved
Functional benefit
Brands
- LumineticsCore: FDA-cleared autonomous AI diagnostic platform for detecting diabetic retinopathy at the point-of-care without physician input.
- SphereDx
- Luminetics Product Line Training
Products and services
- LumineticsCore FDA-cleared autonomous AI diagnostic system that detects diabetic retinopathy (including macular edema) at the point-of-care without physician input. The system analyzes retinal images captured via fundus camera (Topcon NW400) and provides diagnostic results within 30 seconds, determining whether patients should be referred to eye care specialists or retested in 12 months. Indicated for adults aged 22 or older diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.
- SphereDx Proprietary secure hosted data platform for Digital Diagnostics systems, providing centralized access to LumineticsCore patient records, interactive analytics for exam counts and diagnosability rates, data filtering by clinic and date, PDF result downloads, and Excel export for advanced analysis.
- Luminetics Product Line Training Training and support program for LumineticsCore operators and clinical staff, providing courses to gain expertise in the autonomous AI technology, product operation, and best practices for implementation.
Quantifiable outcome
- Time-to-follow-up for diabetic retinopathy referral reduced from 60 days to 5 days at Tarzana Treatment Centers
- +8 more outcomes
Companies that use Digital Diagnostics
Customer profileNamed customers15 records
Segments4 records
Ideal customer profiles3 records
Digital Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability3 records
Feature5 records
Digital Diagnostics partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered core, minor and strategic.
- Cleveland CliniccoreDigital Diagnostics announced a partnership with Cleveland Clinic to embed its LumineticsCore AI technology into primary care and endocrinology visits, expanding access to diabetes-related eye exams. This partnership reflects the growing integration of autonomous AI diagnostics into routine clinical workflows at a leading US health system.
- Penn MedicineminorDigital Diagnostics hosted a community outreach event (Diabetes Eye Day) at Penn Medicine in Pennsylvania, conducting approximately 40 diabetic eye exams in one morning using LumineticsCore. Demonstrates community health partnership and real-world deployment validation.
- Tamer Group / Tamer HealthcarecoreDigital Diagnostics entered a strategic partnership with Tamer Group to launch LumineticsCore in the Kingdom of Saudi Arabia. Tamer Group holds regulatory approvals from both the U.S. FDA and Saudi FDA Authority. Tamer Group commands over 40% of the local vaccine market in Saudi Arabia and is a major healthcare distribution company in the region.
- Google CloudstrategicDigital Diagnostics and Google Cloud announced a collaboration to combat diabetic retinopathy in the Kingdom of Saudi Arabia. The collaboration leverages Google Cloud's infrastructure to support the deployment of LumineticsCore in Saudi Arabia alongside Tamer Group distribution.
- ArchWell HealthcoreDigital Diagnostics partnered with ArchWell Health, a rapidly scaling Medicare Advantage organization, for early detection of diabetic retinopathy. ArchWell Health deployed LumineticsCore across its primary care clinics to improve annual eye exam compliance among diabetic members.
- BaxterstrategicDigital Diagnostics and Baxter announced a new partnership (March 2022) to advance autonomous AI diagnostic solutions for diabetic eye disease. The nature and scope of the partnership was announced but specific details are not fully disclosed in available sources.
- Orbis InternationalstrategicDigital Diagnostics and Orbis International announced a clinical study to help save sight in Bangladesh, evaluating autonomous AI for diabetic eye disease screening in a developing country healthcare system. The study demonstrated a 40% productivity increase for healthcare workers using the AI system, published as the first randomized trial on efficiency gains of autonomous AI.
- University of IowastrategicDr. Michael Abramoff serves as Robert C. Watzke, MD Professor of Ophthalmology and Visual Sciences at the University of Iowa with a joint appointment in the College of Engineering. The company has deep academic roots at the University of Iowa and collaborates on research. UI Research Foundation and UIHC Ophthalmology are listed as research partners on the company website.
- University of Arizona (College of Optical Sciences)minorListed as a research partner on the Digital Diagnostics research page. The University of Arizona College of Optical Sciences contributes to imaging and optical technology research relevant to fundus camera systems used with LumineticsCore.
- Topcon Healthcare (NW400 Camera)coreLumineticsCore is indicated for use with the Topcon NW400 retinal camera. Topcon is a key technology integration partner providing the hardware camera component of the diagnostic system. The company also partnered with Topcon Healthcare in April 2025 for autonomous diabetic retinopathy screening AI integration into the Topcon NW500 fundus camera.
- Epic Systems (EHR Integration)coreLumineticsCore integrates with Epic EHR systems, enabling seamless workflow integration for health system customers. Epic integration was highlighted as a key enabler of adoption at Tarzana Treatment Centers and other health system customers.
Scale indicators5 records
Recent moves6 records
Expansion highlights6 records
Digital Diagnostics competitors and assessment
Company assessmentDirect peers
- AEYE Health: AEYE Health offers AEYE-DS, an FDA-cleared autonomous AI for diabetic retinopathy screening using a single retinal image per eye. Targets the same primary care and endocrinology workflows as Digital Diagnostics with a focus on portable cameras.
- Eyenuk: Eyenuk develops EyeArt, an FDA-cleared AI system for autonomous diabetic retinopathy screening from retinal images. Direct competitor to LumineticsCore in primary care point-of-care DR detection with similar workflow integration and CPT reimbursement model.
- IRIS (Intelligent Retinal Imaging Systems): IRIS provides tele-ophthalmology and AI-enabled retinal screening solutions for primary care, directly competing with LumineticsCore on diabetic retinopathy detection at the point-of-care with health system customers.
Emerging players
- Aidoc: Aidoc develops clinical AI for medical imaging triage and detection across radiology (CT, X-ray). Comparable as an autonomous AI medical imaging company pursuing FDA clearances and health system enterprise sales, though focused on different anatomies.
- Viz.ai: Viz.ai is a leading autonomous AI diagnostics company (e.g., stroke detection on CT) sold to hospitals and IDNs. Comparable as a venture-backed autonomous clinical AI business with CPT reimbursement and enterprise health system GTM motion.
- Thirona: Thirona develops RetCAD and other AI tools for retinal image analysis, including DR detection and broader ocular pathology. An emerging specialist in medical image AI with overlapping clinical research collaborations.
- RetinaLyze: RetinaLyze offers AI-based retinal image analysis for diabetic retinopathy and other ocular conditions. Focused primarily on European and emerging markets, providing comparable screening-as-a-service to optometry and primary care clinics.
Broad incumbents
- Heidelberg Engineering: Heidelberg Engineering provides SPECTRALIS and other retinal imaging systems used by ophthalmologists. A broad incumbent in diagnostic imaging with growing AI/HEYEX software ecosystem that touches the same end customers.
- ZEISS Medical Technology: ZEISS offers ophthalmic diagnostic devices (e.g., CLARUS, CIRRUS) and FORUM/ZEISS AI-enabled analytics. A broad incumbent in eye care imaging and diagnostics with expanding software/AI capabilities that overlap with Digital Diagnostics' screening vision.
- Topcon Healthcare: Topcon is the primary fundus camera hardware partner for LumineticsCore (NW400/NW500). A broad incumbent in ophthalmic imaging that increasingly integrates its own AI and screening software, representing both a partner and potential competitive threat.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Digital Diagnostics social profiles
Digital presenceDigital Diagnostics compliance and trust
Trust signalCompliance1 record
Digital Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Digital Diagnostics leadership team
Management profileNumber of profiles
Profiles14 records
Digital Diagnostics funding detail
Funding detailFunding overview
Funding rounds7 records
Investors11 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Digital Diagnostics M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Digital Diagnostics
What does Digital Diagnostics do?
Digital Diagnostics develops and sells LumineticsCore, the first FDA De Novo-cleared autonomous AI diagnostic system that detects more than mild diabetic retinopathy at the point-of-care without physician input, delivering results within 30 seconds of image submission. The platform is supported by SphereDx, a secure hosted platform for diagnostic results and analytics, and is reimbursable via CPT code 92229, enabling health systems to perform diagnostic-grade diabetic eye exams in primary care settings.
Is Digital Diagnostics a public or private company?
Digital Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Digital Diagnostics founded?
Digital Diagnostics was founded in 2018. It employs 101 to 250 people.
Where is Digital Diagnostics based?
Digital Diagnostics is headquartered in Coralville, United States, in the North America region.
How does Digital Diagnostics make money?
Two revenue lines are on record. Autonomous AI Diagnostic Reimbursement (CPT 92229) is the primary driver. The others are enterprise Software/SaaS (SphereDx).
Who are Digital Diagnostics's main competitors?
Direct peers on record are AEYE Health, Eyenuk and IRIS (Intelligent Retinal Imaging Systems). Emerging players are Aidoc, Viz.ai, Thirona and RetinaLyze. Broad incumbents are Heidelberg Engineering, ZEISS Medical Technology and Topcon Healthcare.
Does Digital Diagnostics have an API?
No public API is recorded for Digital Diagnostics.
What industry is Digital Diagnostics in?
Digital Diagnostics's product category is AI Diagnostic Software / Autonomous Medical Imaging AI. Its primary akta.pro industry code is HDAAAEAH, Medical Imaging AI, with a secondary code of HLAAALAO, Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays). Its NAICS code is 62151 and its SIC code is 3845.