Release date: 2018-04-12
Just now, the US FDA approved the first medical device IDx-DR, which uses artificial intelligence to detect retinopathy of diabetic patients. IDx-DR is the first medical device to receive marketing authorization to provide screening decisions without the need for a clinician to interpret images or results, which allows doctors who are not normally involved in eye care to use the device.
Diabetic retinopathy occurs when hyperglycemia causes damage to the retinal blood vessels, the photosensitive tissue at the back of the eye. Diabetic retinopathy is the most common cause of blindness in patients and is the leading cause of visual impairment and blindness in adults at working age.
Developed by IDx, IDx-DR is a software program that uses artificial intelligence algorithms to analyze eye images taken by the Recone Camera Topcon NW400. The doctor uploads the patient's digital image of the retina to the cloud server on which the IDx-DR software is installed. If the image quality is acceptable, the software can provide the doctor with one of two results: 1) "Discovering mildly above diabetic retinopathy: referral to an ophthalmologist"; or 2) "No mild to diabetic retinopathy found , review within 12 months." If the test results are positive, the patient should contact an ophthalmologist as soon as possible for further diagnostic evaluation and treatment.
The approval was based on FDA's assessment of clinical study data on retinal images of 900 diabetic patients at 10 major treatment sites. The study was designed to assess the accuracy of IDx-DR in detecting mild to diabetic retinopathy. In this study, IDx-DR was able to correctly identify 87.4% of patients with mild or above diabetic retinopathy, and 89.5% of patients were able to correctly identify no more than mild diabetic retinopathy.
IDx-DR workflow (Source: IDx official website)
Patients not eligible for IDx-DR screening for diabetic retinopathy include history of laser treatment, history of surgery or intraocular injection, persistent loss of vision, blurred vision, floaters, previous diagnosis of macular edema, severe non-proliferative retina Lesions, proliferative retinopathy, radiation-induced retinopathy, retinal vein occlusion, and pregnant diabetics.
"The early detection of retinopathy is an important part of the disease management of millions of diabetic patients, but many diabetic patients do not adequately screen for diabetic retinopathy, because about 50% of them cannot guarantee an annual ophthalmologist," FDA Dr. Malvina Eydelman, Director of the Department of Otolaryngology and Equipment, Radiation Health Center, said: "Today's decision enables new artificial intelligence technology to be used in primary care physicians' offices. FDA will continue to promote the availability of safe and effective digital medical devices to improve patient access. The health care opportunities you need."
We expect this new device to help doctors and diabetics detect retinopathy early and avoid blindness.
Reference materials:
[1] FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
[2] IDx official website
Source: WuXi PharmaTech
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