Company profile

Digital Diagnostics

Medical Imaging & Radiology

Company profile

About Digital Diagnostics

Digital Diagnostics is a pioneering AI diagnostic healthcare technology company committed to transforming healthcare quality, accessibility, and affordability worldwide. The company made history as the first to receive FDA clearance for an autonomous AI diagnostic platform that makes diagnoses without physician input. Their flagship product, LumineticsCore, is an AI diagnostic system that autonomously diagnoses diabetic retinopathy (including macular edema) in patients with diabetes at the point-of-care. The system uses a fundus camera to capture retinal images, which are then analyzed by the AI algorithm within 30 seconds to provide diagnostic results without requiring specialist overread or telemedicine callbacks. LumineticsCore is reimbursable using CPT code 92229 and helps close care gaps for diabetes eye exams, improving HEDIS and MIPS scores and Stars ratings. The company's approach to AI is built on an ethical foundation, with the system modeled to make decisions based on the same clinical disease detectors that eye care specialists would use. Digital Diagnostics serves front-line care providers, ophthalmologists, optometrists, payors, and patients, helping to prevent vision loss and blindness through early detection while improving healthcare efficiency and access to care.

Company description Digital Diagnostics official website

Primary marketMedical Imaging & Radiology
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Diabetic macular edema
  • Diabetic retinopathy

Who it serves

  • Community health centers
  • Health systems
  • Ophthalmologists
  • Optometrists
  • Payers
  • Primary care providers

Deployment & integration

Cloud Saas · Other deployment with recorded integration context.

Recorded integration context: Epic.

Geographic context

MarketsGlobal · United States
Company sourceOfficial website

Company milestones

Platform expansion

First FDA clearance for autonomous AI diagnostic platform. Multiple successful deployments across health systems. Reimbursement established with CPT code 92229.

Partnerships

Recorded partners

  • AbsoluteCare Healthcare System
  • Cahaba Medical Care
  • Johns Creek Primary Care
  • OSF Healthcare
  • Tarzana Treatment Centers
  • University Medical Center
  • Urban Health
  • Zufall Health

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

Luminetics Product Line Training

Comprehensive training and support for LumineticsCore technology

Service · OtherCompany source

LumineticsCore

FDA-cleared AI that autonomously diagnoses diabetic retinopathy at the point-of-care without physician input

Software · Cloud SaaSCompany source

SphereDx

Securely hosted diagnostic results platform built for Digital Diagnostics systems

Platform · Cloud SaaSCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

Evidence position

Publications, clinical validation, and regulatory records connected to this Company appear here.

Research

Publications & preprints

Neuroretinal Layer Thinning on OCT Imaging and Hemoglobin A1c in Youth With Type 1 Diabetes.

JAMA ophthalmology · Jun 25, 2026

Diabetic retinal disease cure accelerator: Modernizing staging and endpoints.

Progress in retinal and eye research · May 21, 2026

Single-cell profiling of peripheral blood mononuclear cells from patients treated with oncolytic adenovirus TILT-123 reveals baseline immune status as a predictor of therapy outcomes.

Cancer gene therapy · Jun 1, 2025

Cost-effectiveness of AI for pediatric diabetic eye exams from a health system perspective.

NPJ digital medicine · Jan 2, 2025

Mitigation of AI adoption bias through an improved autonomous AI system for diabetic retinal disease.

NPJ digital medicine · Dec 19, 2024

Expert-level detection of M-proteins in serum protein electrophoresis using machine learning.

Clinical chemistry and laboratory medicine · Nov 26, 2024

Clinical validation

Clinical-trial records

Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

NCT06763952 · Mentioned · NOT YET RECRUITING

Telemedicine Self-examination of Speech and Memory for Rapid Detection of Cognitive Impairments Using Machine Learning Methods

NCT07558785 · Mentioned · ENROLLING BY INVITATION

Development of Digital Services for Parkinson's Disease

NCT06733077 · Mentioned · RECRUITING

Camera Qualification Study

NCT05808699 · Sponsor · ACTIVE NOT RECRUITING

Digital Diagnostics and Intervention Services for Parkinson's Disease

NCT06534177 · Mentioned · NOT YET RECRUITING

RAE (Realize, Analyze, Engage)

NCT05227339 · Mentioned · COMPLETED

Regulatory

Regulatory records

IDx-DR v2.3

K213037 · 510k · Jun 17, 2022

IDx-DR

K203629 · 510k · Jun 10, 2021

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

91% reduction in unnecessary specialty visits

Pivotal clinical trial

Adherence rates increased from 16.2% to 50.7%

Johns Creek Primary Care case study

1 in 3 patients diagnosed with diabetic retinopathy

Cahaba Medical Care within 90 days

60% over target for annual eye exams

Urban Health case study

Reduction in time-to-follow-up from 60 days to 5 days

Tarzana Treatment Centers

Over 60,000 people prevented from going blind annually

Diabetic retinopathy prevention

$5B+ annual savings potential

100% compliance for diabetic retinopathy exams

AbsoluteCare Healthcare System

Streamline care during wellness checks and preserve vision for people living with diabetes

Allowed providers to effectively determine if a patient needed follow-up care during wellness visits

Cahaba Medical Care

Address health equity and detect diabetic retinopathy in high-risk patient population

Within 90 days, diagnosed one out of every three people tested with diabetic retinopathy

Johns Creek Primary Care

Increase diabetic retinopathy screening adherence rates in primary care setting

Adherence rates with diabetic retinal exams increased from 16.2% to 50.7% year over year

OSF Healthcare

Early detection of diabetic retinopathy changes not visible to human eye

Nearly one-quarter of all patients with diabetes tested positive for diabetic retinopathy

Tarzana Treatment Centers

Improve rates of annual eye exams and reduce time-to-follow-up in complex patient population

Reduced time-to-follow-up from 60 days with remote reading network to 5 days with LumineticsCore

University Medical Center (UMC)

Improve efficiency of diabetic eye exam screening process

More efficient system that allows for more exams to be conducted

Urban Health Plan (UHP)

Exceed quality targets for eye exams for diabetes and improve provider efficiency

Went from 40% below target of 1000 annual eye exams to 60% over target after implementation

Zufall Health

Provide crucial feedback for diabetes care intensification through organ damage identification

Identification of organ damage provided feedback for intensifying diabetes care

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

06 · Company updates

Updates from Digital Diagnostics

Recent articles published on Digital Diagnostics's official website.

No Company updates are currently listed.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Medical Imaging & Radiology

Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.

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10 · Pro research

Coming soon

Expanded Company research is in development.

Health AI Central Pro · Coming Soon

Deeper Company research is coming soon.

Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.

ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

Coming Soon