Overview

IDx-DR

IDx-DR is a Class IIa Medical Device and the first ever FDA De Novo cleared autonomous AI.

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Our Mission

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.

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Our Vision

To be the world leader in developing safe, effective, and equitable AI platforms that improve patient outcomes.

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Close Care Gaps, Prevent Blindness

IDx-DR

IDx-DR is an AI diagnostic system that autonomously diagnoses patients for diabetic retinopathy and macular edema

With IDx-DR you get:

  • Diagnostic results at the point-of-care
  • No need for specialist overread or telemedicine call backs
  • A simple user interface
  • Customized workflow integration solutions
  • +64M people with diabetes in Europe
  • 8% of individuals in EU go blind annually from DR
  • 58% of patients with diabetes fail to get proper eye care

How IDx-DR Works

1

Using a fundus camera, the trained operator captures two images per eye

2

The images are submitted to IDx-DR

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3

IDx-DR analyzes images for signs of diabetic retinopathy and macular edema, providing results in less than 30 seconds

Results

No disease detected: Retest in 12 Months

Results

Disease detected: Refer to an eye care professional

IDx-DR – How It Works | Play Video

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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.

  • Diagnostic AI built on an ethical foundation
  • Diagnostic results at point-of-care
  • Infinitely scalable

High Performance in a
Real-World Clinical Setting

Safety

IDx-DR was validated against patient outcomes using a surrogate outcome standard to keep patient safety the main priority. In the pivotal clinical trial, IDx-DR referred 100% of patients with at least moderate diabetic retinopathy and more than 96% of patients with diabetic macular edema.

Effective

In our pivotal clinical trial, IDx-DR avoided 91% of unnecessary specialty visits by capturing a result that is negative for diabetic retinopathy and macular edema at the point-of-care.

Equitable

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.

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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.  

Digital Diagnostics

info@digitaldiagnostics.com
2300 Oakdale Blvd.
Coralville, IA 52241

Media Contact

Jacque Engle
engle@digitaldiagnostics.com