FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

FDAThe U.S. Food and Drug Administration today 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 occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.

"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," said 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. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care."

The device, called IDx-DR, is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. A doctor uploads the digital images of the patient's retinas to a cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) "more than mild diabetic retinopathy detected: refer to an eye care professional" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.

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, which makes it usable by health care providers who may not normally be involved in eye care.

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, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 percent of the time.

Patients who have a history of laser treatment, surgery or injections in the eye or who have any of the following conditions should not be screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. IDx-DR should not be used in patients with diabetes who are pregnant; diabetic retinopathy can progress very rapidly during pregnancy and IDx-DR is not intended to evaluate rapidly progressive diabetic retinopathy. IDx-DR is only designed to detect diabetic retinopathy, including macular edema; it should not be used to detect any other disease or condition. Patients will still need to get a complete eye examination at the age of 40 and at the age of 60 and also if they have any vision symptoms (for example, persistent vision loss, blurred vision or floaters).

IDx-DR was reviewed under the FDA's De Novo premarket 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 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: the device 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.

The FDA is permitting marketing of IDx-DR to IDx LLC.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

NHS Staff Punished as 500,000 Rely on Wh…

WhatsApp, Facebook Messenger and other unauthorised instant messaging (IM) apps are being used by approximately 500,000 NHS staff at work, as a growing number turn to consumer tools to communicate...

Call for Abstracts: European Telemedicin…

27 - 29 May 2018, Sitges, Barcelona, Spain. The European Telemedicine Conference 2018 (ETC18) is an interdisciplinary forum for healthcare professionals, directors, managers, and researchers with the intent of bringing together...

conhIT 2018: The stage is Set for Dialog…

17 - 19 April 2018, Berlin, Germany. Finding out about and supporting all aspects of the digital transformation of the healthcare system: that is what this year's conhIT, Europe's largest event...

Smartphone 'Scores' can Help Doctors Tra…

Parkinson's disease, a progressive brain disorder, is often tough to treat effectively because symptoms, such as tremors and walking difficulties, can vary dramatically over a period of days, or even...

Focus on the Digital Transformation - A …

17 - 19 April 2018, Berlin, Germany. How is the digitalisation of the healthcare system affecting the relationship between patients and doctors? What new innovations and solutions does the health IT...

Portable Device Detects Severe Stroke in…

A new device worn like a visor can detect emergent large-vessel occlusion in patients with suspected stroke with 92 percent accuracy, report clinical investigators at the Medical University of South...

Imitation is the Most Sincere Form of Fl…

For every two mobile apps released, one is a clone of an existing app. However, new research published in the INFORMS journal Information Systems Research shows the success of the...

Merck Partners with Medisafe to Help Imp…

Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication intake and adhere to prescribed treatment regimens...

Philips Research-led Big Data Consortium…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, together with its consortium partners, today announced that it has received funding from the EU's Horizon 2020 program...

Smartphone App Performs Better than Trad…

A smartphone application using the phone's camera function performed better than traditional physical examination to assess blood flow in a wrist artery for patients undergoing coronary angiography, according to a...

Deep Learning Transforms Smartphone Micr…

Researchers at the UCLA Samueli School of Engineering have demonstrated that deep learning, a powerful form of artificial intelligence, can discern and enhance microscopic details in photos taken by smartphones...