Digital Diagnostics

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.

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

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

• Autonomous AI diagnostics
• Diabetic retinopathy detection
• Medical imaging AI
• Point-of-care diagnostics
• FDA-cleared healthcare AI

Headquarters

HQ city

Coralville

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, Others

Revenue model

1. 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.
2. 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

Go-to-market motion2 records

Distribution channels5 records

Marketing channels7 records

Core 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

Named customers15 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability3 records

Feature5 records

Partnerships

Eleven partnerships are on record, tiered core, minor and strategic.

• Cleveland CliniccoreStrategic or Co-development Partner · 7 May 2026Digital 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 MedicineminorStrategic or Co-development Partner · 7 May 2026Digital 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 HealthcarecoreChannel Partner/ Reseller/ Distributor · 2 February 2025Digital 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 CloudstrategicTechnology or Integration · 1 November 2024Digital 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 HealthcoreStrategic or Co-development Partner · 1 July 2022Digital 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.
• BaxterstrategicStrategic or Co-development Partner · 9 March 2022Digital 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 InternationalstrategicStrategic or Co-development Partner · 15 June 2021Digital 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 IowastrategicStrategic or Co-development PartnerDr. 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)minorStrategic or Co-development PartnerListed 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)coreTechnology or IntegrationLumineticsCore 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)coreTechnology or IntegrationLumineticsCore 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

Direct 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

• YouTubeyoutube.com/channel/UCz9xjA0Z9_4Z9Z9Z9Z9Z9Z
• Facebookfacebook.com/DigitalDXS
• LinkedInlinkedin.com/company/digital-diagnostics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds7 records

Investors11 records

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

M&A1 record

Investments

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

Frequently asked questions about Digital Diagnostics