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Digital Diagnostics’ flagship product, LumineticsCore™ (formerly IDx-DR), is the first FDA-cleared autonomous AI diagnostic system designed to detect diabetic retinopathy (including macular edema), a common complication of diabetes and a leading cause of blindness.

In the early stages diabetic retinopathy is mostly symptomless, but in the later stages people may experience blurred vision, spots, and sudden loss of vision. If caught and treated early, it is possible to prevent the symptoms that occur in the later stages.

LumineticsCore is modeled to look for and make decisions based on the same clinical disease detectors that eyecare specialists would use. The system utilizes artificial intelligence (AI) to analyze images from a specialized retinal camera to identify signs of diabetic retinopathy (including macular edema), enabling it to autonomously deliver a diagnosis at the point-of-care.

LumineticsCore has been trained and validated to mitigate bias and ensure the system works equally well for all people, regardless of age, sex, race, or ethnicity. The LumineticsCore pivotal trial included over 900 participants to demonstrate its effectiveness in accurately reading images representative of the intended patient population.

When LumineticsCore provides a positive diagnosis of diabetic retinopathy, the patient is referred to an eyecare specialist to develop a management or treatment plan. LumineticsCore’s AI technology helps primary care doctors identify the disease in their office, eliminating the need for the patient to visit a specialist unless they receive a positive diagnosis.

As of today, Digital Diagnostics’ customers have tested and identified thousands of patients with disease who were previously undiagnosed.

By bringing high-quality diagnostic services to the point-of-care and meeting patients where they are, LumineticsCore bridges the gap between specialty and primary care, delivering accessibility, affordability, equity, and high-quality healthcare globally, using technology.

Check out our Product Video to learn more about LumineticsCore, an AI diagnostic system that autonomously diagnoses patients for diabetic retinopathy.