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 globe.