Iowa-based artificial intelligence (AI) diagnostics company IDx recently received market approval from the FDA for its AI-based medical device, IDx-DR, to detect greater than a mild level of diabetic retinopathy in adults. As the first of its kind to be authorized for commercialization, IDx-DR has the potential to increase productivity and accessibility, and reduce costs in the US healthcare system, says data and analytics company GlobalData.
IDx-DR was granted breakthrough device designation by the FDA, allowing the company to receive intensive interaction and guidance from the FDA during its development, and was reviewed under the De Novo premarket review pathway, a regulatory pathway created by the FDA for novel low- to moderate-risk devices in spaces where there is no prior, legally marketed device.
Alice Stevens, MBiol, Healthcare Analyst at GlobalData, says: “Diabetic retinopathy is the most common cause of vision loss among diabetic patients and the leading cause of vision impairment among the US working-age population. Early detection of this disease is crucial in detecting and preventing further vision loss. However, despite this, 50% of diabetic patients fail to see an eye specialist once per year.”
In a clinical study involving retinal images from more than 900 diabetic patients at 10 primary care sites, IDx-DR was able to correctly diagnose more than mild diabetic retinopathy 87.4% of the time, and was able to correctly identify those patients who did not have more than mild diabetic retinopathy in 89.5% of cases.
“Not only will IDx-DR provide the opportunity to increase the screening rate of diabetic eye disease, which is currently underdiagnosed in the US, but will also reduce the burden to diabetic patients who are presently plagued by multiple, frequent visits to varying doctors and specialists,” Ms. Stevens said. “It has the potential to limit both the detrimental impact diabetic retinopathy can have on a patient’s life and the burden that the disease places on the US healthcare system.”
This is not the first incident where the potential of AI within diabetes has been realized. An AI network developed by Cardiogram was able detect individuals at risk of diabetes in a recent study with 85% accuracy, solely through the use of a smart watch.
While the scope and impact of AI is not yet fully understood, GlobalData anticipates AI-based medical devices will increasingly be incorporated into the diagnosis and management of not only diabetes, but will also play an important future role in our approach across multiple indications.