Products

IDx-DR
Digital Diagnostics
Ophthalmology AI
IDx-DR, now LumineticsCore®, is the first FDA-cleared autonomous AI diagnostic system for the automatic detection of more-than-mild diabetic retinopathy (mtmDR) in adults with diabetes. It uses retinal images captured by a Topcon NW400 camera to provide rapid results in primary care settings, aiming to improve access to early detection and prevent vision loss.

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About Digital Diagnostics

Digital Diagnostics is a pioneering healthcare technology company that develops and implements artificial intelligence (AI) systems to diagnose diseases by analyzing high-quality images. Their mission is to enhance the accessibility, affordability, and quality of healthcare globally by creating technology that benefits patients. The company is recognized for developing the first FDA-cleared autonomous AI diagnostic platform, LumineticsCore® (formerly IDx-DR), which can make clinical decisions without human intervention. This platform is designed to detect diabetic retinopathy, including diabetic macular edema, at the point-of-care, aiming to increase patient access to care and expedite referrals for specialist treatment when needed.

Digital Diagnostics emphasizes an ethical approach to AI in healthcare, working with regulators, providers, and patient advocacy groups to establish AI diagnosis as a new standard of care. Their autonomous systems are intended to remove the diagnostic burden of common diseases from specialists, allowing for improved patient outcomes through precise and affordable disease diagnosis. Beyond diabetic retinopathy, the company is actively researching additional applications for AI-based diagnostic solutions using fundus imaging, including exploring glaucoma, cardiovascular indications, age-related macular degeneration (AMD), and neurodegenerative indications. They also offer SphereDx, a secure data platform that integrates with LumineticsCore for centralized access to exam results and real-time monitoring of key performance metrics.

Focus Areas

AI diagnostics diabetic retinopathy autonomous AI healthcare accessibility healthcare affordability health equity medical imaging analysis early disease detection

Business Intelligence

TechnologyAI-based diagnostic platform, autonomous AI algorithms, biomarker-based approach, deep learning, computer vision for medical imaging, cloud-based clinical result platforms, EHR interoperability

What Physicians Need to Know

AI Diagnostics & Autonomous AI
Digital Diagnostics is a pioneer in autonomous AI, developing systems that can diagnose diseases by analyzing high-quality images without direct human input. Their flagship product, LumineticsCore®, is the first FDA-cleared autonomous AI diagnostic system for diabetic retinopathy. This technology aims to make clinical decisions independently, removing the diagnostic burden of common diseases from specialists.
Diabetic Retinopathy
Their primary product, LumineticsCore®, autonomously detects more than mild diabetic retinopathy (mtmDR) and diabetic macular edema (DME) in adults with diabetes who have not been previously diagnosed with diabetic retinopathy. This system provides diagnostic results at the point-of-care, increasing patient access to sight-saving diagnoses and allowing non-eyecare providers to offer specialty-level exams.
Healthcare Accessibility, Affordability & Equity
Digital Diagnostics is committed to transforming global healthcare by increasing access, reducing costs, and improving the quality and equity of care. Their autonomous AI solutions help address health disparities, particularly in underserved populations, by bringing diagnostic capabilities to where patients already are.
Medical Imaging Analysis & Early Disease Detection
The company specializes in analyzing high-quality medical images using AI to diagnose diseases. Their focus on early disease detection, particularly with LumineticsCore®, helps prevent vision loss and blindness by identifying diabetic retinopathy in its early stages. AI-powered diagnostics, in general, are transforming early disease detection across various conditions by analyzing imaging, pathology slides, and multiomic data to spot subtle patterns.
Key Differentiators
Digital Diagnostics is distinguished by being the first company to receive FDA clearance for an autonomous AI diagnostic platform that makes a diagnosis without physician input. They also pioneered the creation of the first autonomous AI CPT® category 1 code for billing and payment (92229) and its inclusion in the American Academy of Ophthalmology's diabetic retinopathy Preferred Practice Pattern. Their approach is built on a foundation of bioethical principles, ensuring safe, effective, and equitable autonomous platforms.
Technology Stack
While specific proprietary details are not fully disclosed, Digital Diagnostics leverages advanced artificial intelligence and deep learning algorithms to analyze medical images. Their systems are designed to 'think' like a physician using a patented biomarker-based approach. They integrate with EHR systems and utilize advanced computing technologies, such as those from NVIDIA, to deliver real-time and reliable diagnostic results. Cloud-based digital platforms are also crucial for secure data storage, collaboration, and AI-powered data processing in digital diagnostics.
Physician Tip

For physicians, Digital Diagnostics' LumineticsCore® offers a significant opportunity to streamline diabetic retinopathy screening by providing autonomous diagnostic results at the point-of-care. This can increase patient compliance with annual eye exams for diabetes, close HEDIS and MIPS care gaps, and allow for immediate actionable next steps. The system can free up specialists by autonomously diagnosing common conditions, enabling them to focus on more complex cases. The availability of a CPT® Category I code (92229) ensures reimbursement for the service. Physicians can leverage this technology to improve patient outcomes through early detection, especially in underserved populations, and enhance overall clinic productivity.

Digital Diagnostics' systems are designed for EHR integration, facilitating seamless workflow within existing healthcare infrastructures. The use of cloud-based platforms in digital diagnostics generally enables secure storage of patient records, collaboration between specialists, and faster access to imaging, simplifying integration between diagnostic equipment and electronic health records. Their technology is indicated for use with specific imaging devices, such as the Topcon TRC-NW400 camera for LumineticsCore®.

Products by Digital Diagnostics

1 product in the directory

IDx-DR
Digital Diagnostics
Ophthalmology AI
IDx-DR, now LumineticsCore®, is the first FDA-cleared autonomous AI diagnostic system for the automatic detection of more-than-mild diabetic retinopathy (mtmDR) in adults with diabetes. It uses retinal images captured by a Topcon NW400 camera to provide rapid results in primary care settings, aiming to improve access to early detection and prevent vision loss.

What the Web Says

Digital Diagnostics is a healthcare AI company that develops autonomous diagnostic systems. Their flagship product, LumineticsCore®, is an AI system designed to diagnose diabetic retinopathy without requiring a physician to interpret the images, aiming to increase access to care and improve patient outcomes. They have also been involved in pioneering FDA-cleared digital cytology systems for cervical cancer screening, which combine AI with advanced imaging to assist in identifying precancerous lesions and cancer cells. Employer reviews indicate a mixed sentiment regarding work-life balance, pay, and management, with some positive experiences and some concerns about negative work culture and changing strategic decisions.

Overall: Mixed

Strengths

  • AI-powered diagnostic systems enhance accuracy and efficiency in disease detection.
  • Increases patient access to specialized care by providing point-of-care diagnostics.
  • Reduces the burden on specialists for common disease diagnoses.
  • Potential to improve patient outcomes through earlier and more precise diagnosis.
  • Pioneering in establishing AI diagnosis as a new standard of care, including FDA clearance and CPT codes.
  • Some employees have found it a great place to learn management skills and enjoyed the work environment.

Limitations

  • Some employer reviews mention a negative work culture.
  • Upper management may not always understand quality regulations and the importance of quality in medical devices.
  • Goals, objectives, and strategic decisions are frequently changing, which can lead to wasted effort.
  • Concerns about job security and advancement opportunities have been raised by employees.
  • One review mentioned disorganized promotion processes with signs of discrimination.
  • Lack of dental plan according to one employee review.

Based on reviews from: Indeed.com, Elion Health, Clinical Pathology Laboratories, SelectScience, Hologic, Digital Diagnostics (company website), Reddit, PitchBook

Last updated: 2026-10-26

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Press & Coverage

PR Newswire
NVIDIA Spotlights Digital Diagnostics as AI Healthcare Pioneer at GTC 2025
Digital Diagnostics was highlighted by NVIDIA at GTC 2025 for its groundbreaking autonomous AI technology, particularly its LumineticsCore® platform for detecting diabetic retinopathy, emphasizing its role in enhancing diagnostic accuracy and accessibility.
2025-03
Digital Diagnostics
Revolutionizing Healthcare Reimbursement: NEJM Paper Highlights Commercial Value of Scaling Adoption of Medical AI
A paper published in the New England Journal of Medicine (NEJM-AI) co-authored by Digital Diagnostics' founder, Michael D. Abramoff, discusses the transformative potential of AI in healthcare, using LumineticsCore™ as an example, and the importance of reimbursement for scalable adoption.
2024-04
Digital Diagnostics
Digital Diagnostics Expands to Lab Settings Increasing Access to Care
Digital Diagnostics announced the expansion of its LumineticsCore™ product into lab settings, with its availability in nine Labcorp patient service centers in Alabama to provide access to diabetic retinopathy exams.
2023-04
Digital Diagnostics
Digital Diagnostics Closes $75 million Series B Funding Round led by KKR
Digital Diagnostics successfully closed a $75 million Series B funding round led by KKR, bringing the company's total funding to over $130 million, to accelerate product development and expand its distribution.
2022-08
Citeline Insights
Digital Endpoints: US FDA Says Start With Outcomes, Not Tech
An FDA white paper on "Digitally Derived Measures" emphasizes that the development of digital endpoints for clinical investigations should prioritize patient outcomes over the capabilities of the digital tools themselves.
2026-10
Taylor & Francis (European Journal of General Practice)
Direct-to-patient digital diagnostics in primary care: Opportunities, challenges, and conditions necessary for responsible digital diagnostics
This peer-reviewed article discusses the opportunities and challenges of direct-to-patient digital diagnostics in primary care, proposing the quadruple aim as a framework to determine the success of these interventions.
2023-11
Digital Diagnostics
Digital Diagnostics: Transforming Global Healthcare With Artificial Intelligence
Digital Diagnostics highlights its LumineticsCore™ product as the most researched autonomous AI diagnostic solution for diabetic eye disease, demonstrating increased adherence rates for diabetic retinal exams in primary care settings.
unknown
Digital Diagnostics
FDA permits marketing of LumineticsCore® (formerly known as IDx-DR) for automated detection of diabetic retinopathy in primary care
The FDA granted IDx (now Digital Diagnostics) De Novo authorization to market LumineticsCore® (formerly IDx-DR), the first autonomous, AI-based diagnostic system for diabetic retinopathy, marking a significant step for AI in healthcare.
2018-04

Frequently Asked Questions

Digital Diagnostics offers an autonomous AI diagnostic system, Luminetics™ (formerly IDx-DR), which is FDA-cleared for the detection of more than mild diabetic retinopathy. This system provides an immediate, AI-powered interpretation of retinal images, enabling early detection and management of the disease directly within the primary care setting.
By bringing diagnostic capabilities to the point of care, Digital Diagnostics' autonomous AI reduces the need for specialist referrals, making screenings more accessible, especially in underserved areas. This approach can lower healthcare costs by facilitating earlier intervention and preventing more severe, expensive complications of diseases like diabetic retinopathy.
The autonomous AI system helps address health equity by providing consistent, high-quality screenings regardless of location or specialist availability, ensuring more patients receive timely diagnoses. Early detection through this technology leads to improved patient outcomes by enabling prompt treatment and slowing disease progression.
Digital Diagnostics prioritizes regulatory compliance, holding the first FDA clearance for an autonomous AI diagnostic system. The company adheres to stringent data security and privacy protocols to protect patient information, ensuring its AI solutions meet the highest standards for safety and effectiveness in clinical use.
While specific pricing details are not publicly available and often depend on the scale of implementation, Digital Diagnostics aims to provide cost-effective solutions. The company offers comprehensive support for implementation, including integration with existing workflows, staff training, and ongoing technical assistance to ensure seamless operation and optimal utilization of their AI platforms.
Digital Diagnostics has formed strategic partnerships with various healthcare organizations and technology providers to integrate its AI solutions into diverse clinical settings. These collaborations aim to enhance the accessibility of their diagnostic platforms and further their mission of improving patient care through autonomous AI.
Digital Diagnostics is a well-established leader in autonomous AI diagnostics, backed by significant investment and a strong track record of innovation. Their long-term vision involves expanding their AI platform to detect a wider range of diseases, continually advancing medical imaging analysis, and ultimately transforming healthcare through accessible and accurate autonomous diagnostics.

Investors

Who's funded Digital Diagnostics.

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