IDx-DR is a Class IIa Medical Device and the first ever FDA De Novo cleared autonomous AI.
To benefit patients by transforming the accessibility, affordability, equity, and quality of global healthcare through the application of technology in the medical diagnosis and treatment process.
To be the world leader in developing safe, effective, and equitable AI platforms that improve patient outcomes.
Close Care Gaps, Prevent Blindness
IDx-DR is an AI diagnostic system that autonomously diagnoses patients for diabetic retinopathy (including macular edema)
With IDx-DR you get:
Using a fundus camera, the trained operator captures two images per eye
The images are submitted to IDx-DR
IDx-DR analyzes images for signs of diabetic retinopathy (including macular edema), providing results in less than 30 seconds
No disease detected: Retest in 12 Months
Disease detected: Refer to an eye care professional
Our Approach to AI Driven Diagnostics
AI the Right Way
IDx-DR was modeled to think like a physician and make decisions based on the same clinical disease detectors that eye care specialists would use.
High Performance in a
Real-World Clinical Setting
IDx-DR has been trained and validated on over 2M images to mitigate bias and ensure the system works equally well for all people, regardless of sex, race, or ethnicity. For more information, read our pivotal trial.
Indications for Use - EU
IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.