IDx-DR with tablet touchscreen

LumineticsCore Logo
LumineticsCore is an Al diagnostic system that autonomously diagnoses patients for diabetic retinopathy (including macular edema)

  • 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 LumineticsCore Works

1

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

2

The images are submitted to LumineticsCore

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3

LumineticsCore analyzes images for signs of diabetic retinopathy (including macular edema), providing results in less than a minute

Results

No diabetic retinopathy detected: Retest in 12 Months

Results

Diabetic retinopathy detected: Refer to an eye care professional

LumineticsCore – How It Works | Play Video

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Our Approach to AI Driven Diagnostics

AI the Right Way™

LumineticsCore 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

LumineticsCore was validated against patient outcomes using a surrogate outcome standard to keep patient safety the main priority. In the pivotal clinical trial, LumineticsCore 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, LumineticsCore 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

LumineticsCore 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

LumineticsCore 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

LumineticsCore 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

LumineticsCore is for eye care providers to help address disparities and improve equity in care as part of the eye exam for people with diabetic retinopathy. LumineticsCore results can lead to 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

LumineticsCore 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

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

dec 12 2018

Indications for Use

LumineticsCore 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. LumineticsCore is indicated for use with the Topcon NW400

LumineticsCore FAQ

What is LumineticsCore?

LumineticsCore 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, LumineticsCore became the first and only FDA De Novo-cleared AI diagnostic system to make a diagnosis without physician input. LumineticsCore is deployed in point-of-care offices across the globe.

What are the indications for LumineticsCore?

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

Warnings

  • LumineticsCore does not replace a full eye exam, but it will find diabetic retinopathy  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 LumineticsCore is reliable, it is not perfect. It is possible that LumineticsCore is unable to detect disease that is present, or possibly give a false positive diagnosis.

To review the LumineticsCore Indications for Use click here.

How does LumineticsCore work?

Using a fundus camera, an operator captures high-quality images of the patients’ eyes. The images are then submitted to LumineticsCore where they are analyzed for signs of diabetic retinopathy. A diagnostic result is provided in within the patient encounter at point-of-care with follow up instructions for the patient based on diagnostic outcome. If disease is detected, the patient is referred to an eye care professional during their appointment where 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 LumineticsCore for?

Patients

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

Providers

LumineticsCore 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 eye exams for people with diabetes quality measures.

Payors

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

Eye Care Providers

LumineticsCore is for eye care providers to help address disparities and improve equity in care as part of the diabetic eye exam delivery model. LumineticsCore results can lead to 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.