The approval last year for the first autonomous artificial intelligence (AI) to make a diagnosis without a physician has opened new doors for the first medical device to use AI to diagnose moderate or worse diabetic retinopathy or macular edema in adults who have diabetes.
Reviewed by Michael D. Abramoff, MD, PhD
A decision by the FDA in April 2018 changed the game for identifying patients at risk of vision loss. Its decision authorized the marketing of an AI system (IDx-DR), that enables the automated detection of diabetic retinopathy in primary care, and marked the first time the agency has granted clearance for an autonomous AI diagnostic system that does not require a physician to interpret results.
This advancement will lead to changes in healthcare delivery by increasing patient access to early detection of diabetic retinopathy, noted Michael D. Abramoff, MD, PhD, the Robert C. Watzke, MD Professor in Retina Research, Department of Ophthalmology and Visual Sciences, University of Iowa Carver College of Medicine, Iowa City. The autonomous AI diagnostic system makes a diagnosis by itself for DR. It requires no human oversight, and, importantly, it aligns with clinical standards.
The system has been designed and tested for use in a primary-care setting, where it can provide a point-of-care diagnosis in a few minutes. The system includes a robotic camera and therefore requires operator training, but training is minimal. Existing staff may be trained in a few hours, even if they have not done retinal imaging.
The algorithm used is based on how clinicians look at DR, meaning it uses machine learning for the detectors that detect the exudates, hemorrhages, micro-aneurysms, and other lesions that indicate DR, noted Dr. Abramoff, who is also founder and chief executive officer of IDx.
The outputs of these detectors are combined leading to two categories at the patient level:
1. No or mild DR, which can be re-examined in 12 months, according to the American Academy of Ophthalmology Preferred Practice Pattern (AAO PPP).
2. More than mild DR and/or ME, which needs to be examined by an eye-care provider and may need treatment, according to the AAO PPP.
Michael D. Abramoff, MD, PhD
E: [email protected]
This article was adapted from Dr. Abramoff’s presentation during a retinal imaging symposium co-sponsored by the Macula Society at the 2018 meeting of the American Academy of Ophthalmology. He is an inventor on patents and patent applications assigned to the University of Iowa. He is founder and CEO of IDx Technologies Inc., and is also a director and shareholder in this company. Dr. Abramoff receives financial support from Alimera Sciences.
1. Abramoff, MD, et al. (2018). “Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices.” npj Digital Medicine. 1(1): 39. https://www. nature.com/articles/s41746-018-0040-6. AI ANALYSIS