FAQ's

Digital Diagnostics (formally IDx) 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 and 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.

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

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 IDx-DR Indications for Use click here.

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