FAQ's

Digital Diagnostics is a pioneering healthcare technology company dedicated to transforming global healthcare through the development and deployment of autonomous artificial intelligence diagnostic systems. Founded by Dr. Michael Abramoff, the company has achieved significant milestones in AI-driven healthcare, emphasizing ethical principles and patient-centric solutions. At its core, Digital Diagnostics aims to enhance the quality, accessibility, and affordability of healthcare worldwide. The company’s mission is to benefit patients by developing technology that makes healthcare easier to access, affordable, available to everyone, and of the highest quality.

LumineticsCore^® is the first FDA-cleared autonomous AI diagnostic platform, capable of making a diagnosis without physician input. This groundbreaking system detects diabetic retinopathy at the point-of-care, providing immediate results and facilitating timely interventions. The implementation of LumineticsCore has led to significant improvements in patient outcomes, including Zufall Community Health Centers, where adherence rates for the eye exam for diabetes increased from 12% to 30% after the system’s integration. Similarly, at Cahaba Medical Care, within 90 days, LumineticsCore diagnosed diabetic retinopathy in more than 1 out of every 4 patients tested, cases that could have otherwise gone undetected.

Assistive AI is designed to augment human decision-making. In other words, it helps, or assists, humans in making better decisions, faster. In healthcare, assistive AI typically serves as a valuable support tool for medical professionals, aiding in tasks such as evaluating large datasets, taking measurements, and analyzing medical images. Autonomous AI, which functions without direct human supervision, involves the technology making decisions on its own. Additionally, autonomous AI systems can be trained to consider a wide variety of potential outcomes to help reduce bias. As it relates to healthcare, autonomous AI applications are being used to provide medical diagnoses without the need for human interpretation.

LumineticsCore is intended for use by health care providers to automatically detect more than mild diabetic retinopathy, which is ETDRS level 35 or higher in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.

Warnings

LumineticsCore does not replace a comprehensive eye exam, it is intended to find diabetic retinopathy that needs to be examined by an eye doctor. Patients who have blurry vision or other symptoms of vision loss should see an eye doctor right away. While LumineticsCore is reliable, it is not perfect. It is possible that LumineticsCore may be unable to detect disease that is present, or possibly give a false positive diagnosis.

To review the LumineticsCore (formerly IDx-DR) Indications for Use click here.

LumineticsCore is the only fully autonomous AI diagnostic system to be De Novo cleared by the FDA. LumineticsCore is installed in point-of-care settings to increase access for patients by producing rapid diagnostic results that do not require physician overread. By integrating autonomous AI diagnostics into clinical practice, Digital Diagnostics addresses critical barriers in healthcare, such as limited access to specialists and the need for timely disease detection. These solutions not only improve patient outcomes but also enhance healthcare productivity by streamlining diagnostic processes and allowing healthcare providers to focus on patient care.

Diabetic retinopathy (DR) is an eye disease caused by complications from diabetes. High blood sugar levels can make blood vessels in the retina swell, leading to reduced blood flow and abnormal vessel development with the potential to cause permanent vision damage over time. People with diabetes should receive an eye exam each year to identify signs of DR according the the American Academy of Ophthalmology, especially since early stages often do not have obvious symptoms. DR is the number one cause of blindness in working-age adults, but vision loss from DR can be prevented if it is detected early and controlled with effective diabetes management. There are several stages of the disease including, more than mild non-proliferative diabetic retinopathy (NPDR), a stage which may present with blurry vision or floaters as potential symptoms, and proliferative diabetic retinopathy (PDR), a more advanced stage in which central and peripheral vision is at risk.

Early stages of diabetic retinopathy (DR) may have no noticeable symptoms, though disease may still be progressing. Mild symptoms of DR could be attributed to other simple causes such as fatigue or eye strain. The first signs of diabetic retinopathy can be very moderate and are easily overlooked. Many people may not know when they have early-stage diabetic retinopathy. According to the America Academy of Ophthalmology, patients with diabetes should be tested annually for signs of diabetic retinopathy to detect it early and avoid disease progression and potential lasting vision damage.