IDx-DR with tablet touchscreen

Close Care Gaps, Prevent Blindness

IDx-DR

IDx-DR is an AI diagnostic system that autonomously diagnoses patients for diabetic retinopathy (including 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

The Problem: Every Year, Over 60,000 People Go Blind from Diabetic Retinopathy

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 (including 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 is modeled to look for 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 the 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 (including 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.

Monica typing on computer with retina on camera screen and patient leaning into camera wider view

IDx-DR in Action

Digital Diagnostics is impacting patient care across the globe.

Monica typing on computer with retina on camera screen and patient leaning into camera wider view

Front-Line Care Providers

IDx-DR is for medical professionals who want to provide patients with rigorously validated and ethically designed diagnostic results at the point-of-care, allowing for more comprehensive diabetes care and improved performance with diabetic eye exam quality measures.

Ophthalmologists & Optometrists

IDx-DR is for eye care providers to help address disparities and improve equity in care as part of the diabetic eye exam delivery model. IDx-DR outputs can direct more actionable referrals, identifying patients with diabetes, not already under the care of an eye care provider, who are most likely to need timely vision saving interventions.

treating D Retinopathy
jun 25 2019

Payor Community

IDx-DR is for payors to improve healthcare efficiency and access to care for enrollees while supporting the Patient Centered Medical Home (PCMH).

  • Cost savings over the life-time of care
  • Prevent blindness through early disease detection
  • 100% compliance for DR alone saves > $5B/year

Patients

IDx-DR is for adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy or macular edema and are not currently under the care of an eye care specialist. IDx-DR is installed at point-of-care locations to increase patient access and convenience.

dec 12 2018

Indications for Use

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400

IDx-DR FAQ

What is IDx-DR?

IDx-DR detects more than mild diabetic retinopathy, which is ETDRS level 35 or higher (including macular edema) at point-of-care to provide the patient with a diagnostic report without a physician evaluation. After completing a rigorous prospective, preregistered clinical trial at primary care sites across the country, IDx-DR became the first and only FDA De Novo-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.

What are the indications for IDx-DR?

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

Warnings

  • IDx-DR does not replace a full eye exam, but it will find diabetic retinopathy (including diabetic macular edema) 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 IDx-DR is reliable, it is not perfect. It is possible that IDx-DR is unable to detect disease that is present, or possibly give a false positive diagnosis.

To review the IDx-DR Indications for Use click here.

How does IDx-DR work?

Using a fundus camera, an operator captures high quality images of the patients’ eyes. The images are then submitted to IDx-DR where they are analyzed for signs of diabetic retinopathy (including diabetic macular edema). A diagnostic result is provided in within the patient appointment at the point-of-care with follow up instructions for the patient based on the outcome. If disease is detected the patient is referred to an eye care professional when they received their diagnosis, which increases the chances a patient will follow through with the referral. If there is no disease detected the patient is advised to get retested in 12 months.

Who is IDx-DR for?

Patients

IDx-DR is for adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy (including diabetic macular edema) and are not currently under the care of an eye care specialist. IDx-DR is installed at point-of-care locations to increase patient access and convenience.

Providers

IDx-DR is for medical professionals who want to provide patients with rigorously validated and ethically designed diagnostic results at the point-of-care, allowing for more comprehensive diabetes care and improved performance with diabetic eye exam quality measures.

Payors

IDx-DR is for payors to improve healthcare efficiency and access to care for enrollees while supporting the Patient Centered Medical Home (PCMH).

Eye Care Providers

IDx-DR is for eye care providers to help address disparities and improve equity in care as part of the diabetic eye exam delivery model. IDx-DR outputs can direct more actionable referrals, identifying patients with diabetes, not already under the care of an eye care provider, who are most likely to need timely vision saving interventions.

What is autonomous AI?

Autonomous AI is a technology that can make clinical and diagnostic decisions that impact patient care without the need for physician involvement.