In 2018, Digital Diagnostics’ flagship product, LumineticsCore™ (formerly IDx-DR), became the first FDA-cleared AI diagnostic system capable of providing an autonomous diagnosis at the point-of-care without a physician evaluating the images.
LumineticsCore is engineered to identify diabetic retinopathy, a common complication of diabetes and a leading cause of blindness in working age adults. Diabetic retinopathy occurs when high blood sugar levels cause damage to blood vessels in the retina. If left untreated, diabetic retinopathy may lead to vision-threatening diabetic retinopathy, which can result in irreversible blindness.
Fortunately, new technologies and improved ophthalmic imaging diagnostics, such as LumineticsCore, have been developed to bring early diagnosis to the point-of-care. Utilizing autonomous AI to detect diabetic retinopathy (including macular edema), LumineticsCore can identify, diagnose, and recommend next steps at the point-of-care, all without the involvement of an eyecare provider.
LumineticsCore is modeled to look for and make decisions based on the same clinical disease detectors that eye care specialists would use to diagnose diabetic retinopathy. When LumineticsCore provides a positive diagnosis for diabetic retinopathy, the patient is referred to an ophthalmologist or optometrist to develop a management or treatment plan.
LumineticsCore has been rigorously validated against patient outcomes in the intended clinical workflow to keep patient safety the main priority. The LumineticsCore pivotal trial included over 900 participants to help demonstrate its effectiveness in accurately reading images representative of the patient population.
By seamlessly integrating high-quality AI diagnostic capabilities into primary care settings, LumineticsCore can help bridge the gap between specialty and primary care in healthcare delivery. To that end,
Digital Diagnostics is dedicated to transforming healthcare, starting with the creation of one system that can positively impact the lives of patients globally.
Check out our Product Video to learn more about LumineticsCore.