The first artificial intelligence (AI) diagnostic system to gain clearance from the U.S. Food and Drug Administration beat out all predetermined benchmarks, achieving "high diagnostic accuracy" for patients with certain forms of diabetic retinopathy, according to clinical trial findings. IDx, the developer of the system, IDx-DR, published its results this week in the peer-reviewed journal Nature Digital Medicine. The paper provides an inside look into a technology that could transform how the industry diagnoses diabetic retinopathy, a condition that can cause blindness, bringing the process from the specialist's office to primary care -- without the need for a clinician to interpret the results. READ: First-of-Its-Kind AI Tool for Diabetic Retinopathy Detection Approved by FDA "This is formerly uncharted territory in healthcare, making it especially critical that we ensure the highest level of safety before introducing autonomous AI into patient care," Michael D. Abràmoff, M.D., Ph.D., IDx's founder and president and the study's principal investigator, said in a statement. In April, the FDA cleared IDx-DR, which analyzes images of the eye, for detection of "more than mild" diabetic retinopathy in adults with diabetes.

Artificial intelligence (AI) is now being used to autonomously diagnose a diabetes-related eye disorder in patients at University of Iowa Hospitals and Clinics in Iowa City. University of Iowa Health Care is the first U.S. medical center to start using IDx-DR - a technology that uses artificial intelligence (AI) to diagnose diabetic retinopathy, a condition in which poorly controlled blood sugar leads to damaged blood vessels in the back of the eye. IDx-DR is the first device authorized by the FDA for marketing that provides a screening decision without the need for a clinician to also interpret the image or results. Between 12,000 and 24,000 Americans lose their vision to diabetic retinopathy each year, but the condition can be treated if caught early. The IDx-DR system, which is integrated into our electronic health record, allows people with diabetes to get a critical eye exam as part of their regular primary visit, without having to make a separate appointment with an eye specialist. If the AI detects diabetic retinopathy, the patient can be referred to an eye specialist and start treatment, which can prevent blindness.

AI is poised to revolutionize medicine. An overview of the field, with selected applications in ophthalmology. From the back of the eye to the front, artificial intelligence (AI) is expected to give ophthalmologists new automated tools for diagnosing and treating ocular diseases. This transformation is being driven in part by a recent surge in attention to AI's medical potential from big players in the digital world like Google and IBM. But, in ophthalmic AI circles, com puterized analytics are being viewed as the path toward more efficient and more objective ways to interpret the flood of images that modern eye care practices produce, according to ophthalmologists involved in these efforts. The most immediately promising computer algorithms are in the field of retinal diseases.

IDx-DR is a software program that can detect a certain type of eye disease from photos of a human retina, and it was just approved by the US Food and Drug Administration (FDA). This is a huge win for artificial intelligence (AI) and MedTech development: this is the first time the FDA has approved an AI-powered diagnostic device that doesn't require a doctor to interpret the results. Diabetic retinopathy is an eye disease in which an excess of blood sugar damages blood vessels located in the back of the eye. It's the most common vision malady for people afflicted with diabetes, with about 200,000 new cases occurring per year. After photos of a patient's retina are taken with a special retinal camera, IDx-DR's algorithm verifies that the picture quality is good enough to use for analysis.

For the first time, the US Food and Drug Administration has approved an artificial intelligence diagnostic device that doesn't need a specialized doctor to interpret the results. The software program, called IDx-DR, can detect a form of eye disease by looking at photos of the retina. It works like this: A nurse or doctor uploads photos of the patient's retina taken with a special retinal camera. The IDx-DR software algorithm first indicates whether the image uploaded is high-quality enough to get a result. Then, it analyzes the images to determine whether the patient does or does not have diabetic retinopathy, a form of eye disease where too much blood sugar damages the blood vessels in the back of the eye.

Artificial intelligence is a healthcare and technology buzzword right now, but IDx Founder and President Michael Abràmoff is not a Johnny-come-lately to this phenomenon. His journey and that of the company's lead product began over two decades ago in the Netherlands. The product, IDx-DR, is an AI-based diagnostic system meant to be used as a standalone screening tool for diabetic retinopathy. Last week, the company announced that it submitted an application with the FDA, which the agency accepted with a "breakthrough device" designation. In other words, based on its ability to address an unmet medical need, FDA will provide a faster review.