Building the First FDA Approved Autonomous AI in Healthcare –

Screening for early diabetic retinopathy has become more important as diagnostic testing and early treatment of diabetic macular edema is now possible with the injection of intravitreal anti-VEGF compounds as well as long-lasting intravitreal anti-VEGF inserts.

In people with diabetes, too much blood sugar can damage the tiny blood vessels at the back inner wall of the eye (retina) or block them completely. This condition is diabetic retinopathy. Sometimes, tiny bulges (microaneurysms) protrude from the vessel walls, leaking or oozing fluid and blood into the retina. This fluid can cause swelling (edema) in the central part of the retina (macula). This is a serious eye complication called diabetic macular edema that can cause vision problems or blindness.

Primary care physicians often encounter patients with diabetes and refer them to an ophthalmologist  (vitreoretinal specialist) for diagnosis and treatment.  Many patients are non-compliant with seeing an ophthalmologist, especially if they are not symptomatic. Decreases in visual acuity can be subtle and if binocular a patient has no reference to a decrease in visual acuity.  If the macular edema is present in one eye a patient becomes aware and will seek treatment. The provider will most likely be a physician or advanced practice (nurse practitioner).    Some managed care plans require patients to be seen by primary care (family practice or internal medicine).  This can cause serious delays and lead to more serious problems.

Many managed care programs measure the compliance of diabetic patients. Do they comply with a referral to an ophthalmologist?  The rating of health plans is measured by compliance rates for many diseases, including diabetes. Because of advances in electronic health records and data analytics health plans monitor if patients are non-compliant.  Health plans follow up with their members and notify them to see a competent specialist.  If they do not then home testing is available by HealPros with retinal fundus cameras. Fundus photos are obtained digitally and transmitted directly to an ophthalmologist for analysis and reporting.  Until now imaging is analyzed by an ophthalmologist.  The rate of positive findings is fairly low.  The addition of artificial intelligence can be used to screen normals, and refer positive findings to the ophthalmologist.  This allows greater efficiency and lower cost.

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

Building the First FDA-Approved Autonomous AI in Healthcare – Dr. Michael Abramoff and Seth Rainford