In a news release, the regulatory body said that it has “permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease ‘diabetic retinopathy’ in adults who have diabetes.” Diabetic retinopathy – which occurs when high levels of blood sugar lead to damage in the blood vessels of the retina – is the leading cause of vision impairment and blindness among working-age adults.
The approved medical device – called IDx-DR – is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, says the FDA, which makes it usable by health care providers who may not normally be involved in eye care. IDx-DR is a software program developed by IDx LLC (Coralville, IA) that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400.
The digital images of a patient’s retinas are uploaded to a cloud server on which IDx-DR software is installed. After analysis, the software then provides the doctor with one of two results: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” says Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
In coming to its decision, the FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. The study was designed to evaluate how often IDx-DR could accurately detect patients with more than mild diabetic retinopathy. In the study, the software was able to correctly identify the presence of 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 89.5% of the time.
IDx-DR was reviewed under the agency’s De Novo pre-market review pathway – a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. IDx-DR was granted “Breakthrough Device” designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device.
To qualify for such a designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: it must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.
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