Digital Diagnostics


Digital Diagnostics is a healthcare technology company dedicated to transforming healthcare quality, accessibility, and affordability worldwide through ethical AI principles. They pioneer FDA-cleared autonomous AI diagnostic systems, notably for diabetic retinopathy, and focus on improving patient outcomes, health equity, and clinical efficiency. Their mission is to benefit patients by developing technology that makes healthcare easier to access, affordable, and of the highest quality, leveraging bioethical principles to create impactful AI diagnostic systems.

Industries

Artificial Intelligence
Artificial Intelligence (AI)
Biotechnology
Computer Vision
Health Care
Health Diagnostics
Machine Learning
Medical Device
Wellness
Medical Equipment Manufacturing

Nr. of Employees

medium (51-250)

Digital Diagnostics


Patents

Direct medical treatment predictions using artificial intelligence

US-12763179-B2

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Systems and methods for alignment of the eye for ocular imaging

US-12642431-B2

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Parallel optical coherence tomography apparatuses, systems, and related methods

US-12527473-B2

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Tooth decay diagnostics using artificial intelligence

US-12440149-B2

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Hydrogel-based biological delivery vehicle

US-12427105-B2

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Using a set of machine learning diagnostic models to determine a diagnosis based on a skin tone of a patient

US-12322512-B2

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Products

Point-of-care autonomous AI diagnostic system for diabetic retinopathy

Clinical AI software that analyzes retinal fundus images at the point of care to autonomously detect more-than-mild diabetic retinopathy and diabetic macular edema and produce an immediate diagnostic result to guide referral.

LumineticsCore®

An AI diagnostic system that autonomously diagnoses diabetic retinopathy (including macular edema) in patients without physician input.

IDx-DR

An autonomous testing device for the detection of diabetic retinopathy based on artificial intelligence image interpretation.

DermTriage™

A physician-to-physician teledermatology e-consult system that helps detect serious skin conditions at their earlier, more treatable stages.

SphereDx™

A securely hosted diagnostic results platform built for Digital Diagnostics™ systems.


Services

Onboarding, operator training, and ongoing support to deploy image-based AI diagnostic systems in clinical settings.

Cloud-hosted platform for storage, management, and delivery of AI diagnostic outputs to clinical teams with secure access controls.

Operational services consistent with an independent diagnostic testing facility model to support standardized testing workflows and result delivery aligned with billing and throughput needs.

Strategic support for regulatory submissions, payer engagement, and efforts to secure reimbursement coding and inclusion in clinical quality measures and guidelines.

Expertise Areas

  • Autonomous medical imaging diagnostics
  • Clinical validation and real-world evidence generation
  • Regulatory strategy for autonomous AI systems
  • Reimbursement and market access for diagnostics
  • Show More (6)

Key Technologies

  • Deep learning and computer vision for medical imaging
  • Retinal fundus image analysis
  • Image-based biomarker extraction
  • Cloud-based clinical result platforms
  • Show More (3)

News & Updates

Digital Diagnostics was recognized by NVIDIA as an AI healthcare pioneer at GTC 2025.

A recent publication discusses biomarkers for diabetic retinal neurodegeneration and macular edema.

An article highlights Digital Diagnostics' leadership in AI diagnostics, especially LumineticsCore.

A critical review of AI hype in healthcare, mentioning Digital Diagnostics' impactful AI system.

Digital Diagnostics' LumineticsCore featured as a technological advancement in vision care.

Digital Diagnostics' LumineticsCore recognized among 15 impactful AI technologies.

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