FAQ's

Digital Diagnostics is paving the way for automated diagnosis to become the new standard of care. Founded in 2010 by Dr. Michael Abramoff, a physician/scientist and computer engineer, Digital Diagnostics has created a unique, patented biomarker-based approach to build algorithms to “think” like a physician. These algorithms are integrated into easy-to-use systems that can make clinical decisions without human intervention, removing the diagnostic burden of common diseases from specialists. The FDA cleared Digital Diagnostics’ first diagnostic system for diabetic retinopathy (including diabetic macular edema) in 2018, which is rapidly gaining adoption among the largest and most prestigious health systems in the U.S and around the world.

LumineticsCore™ (formerly IDx-DR) instantly detects diabetic retinopathy (including macular edema) in primary care. After completing a rigorous prospective, preregistered clinical trial at primary care sites across the country, LumineticsCore became the first FDA-cleared AI diagnostic system to make a diagnosis without physician input. LumineticsCore is deployed in point-of-care offices across the United States.

Assistive AI takes measurements and helps physicians make decisions, working like a second set of eyes to review medical images, for example. Autonomous AI, in contrast, possesses the capability to make clinical and treatment decisions that impact patient care.

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

LumineticsCore (formerly IDx-DR) is the first fully autonomous AI diagnostic system cleared by the FDA. LumineticsCore is installed in point-of-care to increase access and reduce cost for patients by producing diagnostic results that do not require physician overread.