FDA permits marketing of AI-based device to detect certain diabetes-related eye problems (diabetic retinopathy)


FDA
April 11, 2018
aao


The 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.


The 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.


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.


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.


Originally published at https://www.fda.gov on March 24, 2020.

TAGS: AI Augmented Health Care; Use Cases; Diabetes (diabetic retinopathy); AI Automation; AI Radiology; AI Medical Imaging; FDA Approval; CE Approval



EDITOR´S NOTE

The device was previously approved in 2013 in the European Community (see below)


Fully Automated Diagnostic Device Receives CE Certification; IDx LLC Planning For Rollout Across Europe


IDx LLC

May 06, 2013


IOWA CITY, Iowa, May 6, 2013 /PRNewswire/ — IDx LLC, a company focused on deploying cutting-edge technology to make medical diagnostics more effective, announced earlier today that its first commercial product, IDx-DR, has received CE approval as a Class IIa medical device. CE marking clears IDx-DR for sale in 31 countries that comprise the European Economic Area.

Developed over the course of two decades by a team of the world’s leading retina experts, IDx-DR software runs on a small computer and is capable of detecting diabetic retinopathy with greater sensitivity than trained physicians. It works by running standard fundus photographs through a series of highly-advanced image filters that identify signs of the disease. By tallying these measurements and comparing them to a disease index, the algorithms built into IDx-DR have been able to consistently outperform trained physicians in diagnosing referable diabetic retinopathy.


This is a game-changer,” said IDx CEO, Gary Seamans. “CE IIa certification allows us to market a first-of-its-kind ‘doc in a box’ that heralds a new era for medicine.”

“IDx-DR is also going to help keep a whole lot of people from going blind,” Seamans added. Diabetic retinopathy is currently responsible for almost two million cases of blindness across the planet. The World Health Organization — along with many national health programs across Europe — recommends that every diabetic patient be screened regularly for the disease. If diagnosed early enough, vision loss associated with diabetic retinopathy can be prevented in most cases.

“Replacing a specialist’s annual eye exam with software-based triage is good for doctors, it’s good for patients, and it’s good for anyone worried about the rising cost of healthcare,” said IDx’s co-founder and President, Dr. Michael Abramoff.

“It means one less doctor’s visit for patients with diabetes, who will now be able to have screening done at their primary care or optometrist’s office. It means a new source of revenue for the practitioners providing these screenings — which we think is going to drive adoption. And for the health care system as a whole, there are going to be tremendous cost savings associated with better screening compliance, increased early detection, and more efficient deployment of medical specialists.”


IDx-DR represents the first in a series of diagnostic algorithms that IDx believes will ultimately transfer eye-related disease screening from the offices of ophthalmologists to patients’ medical homes — whether those be family doctors or retail health clinics.

“The back of the eye is very much a ‘window’ into human health,” explained Dr. Abramoff. “Retinal images allow doctors literally to peek inside the body, where blood vessels and nerve tissue provide a wealth of data about a patient’s physical health status.” Some of this information can be used to diagnose eye diseases, like retinopathy, macular degeneration and glaucoma, but fundus photos can also be used to determine which patients are at an increased risk for stroke and heart attack.


The appearance of retinal veins and arteries are real-time health indicators that can all be measured rapidly, painlessly, and non-invasively, using advanced algorithms. IDx-DR is the first in a series of diagnostic algorithms this company is developing.”


Software for these diagnostic technologies will be based on a series of exclusively licensed patents held by the University of Iowa, where the company’s two principal founders, Dr. Michael Abramoff and Dr. James Folk, both retina specialists, hold clinical and academic appointments.

IDx’s Recent History

In 2010, the company came under the veteran leadership of CEO Gary Seamans. Prior to joining IDx, Mr. Seamans directed operations, engineering, marketing, sales, human resources, finance, and strategic planning divisions during a thirteen-year executive management career with AT&T, served with distinction in the U.S. Air Force, and more recently led Westell Technologies as chairman and CEO. Mr. Seamans has been involved with vision research for a number of years as a founding board member of the Institute for Vision Research.

“We have been able to assemble funding for IDx in a relatively short time frame from investors around the country thanks to the advanced stage of the products and also because people are sympathetic to the greater good that’s going to result from deploying IDx’s algorithms,” Seamans said. “People recognize that technology holds the potential to bend the health care cost curve and at the same time preserve, and even enhance, patient care.”

The next step for the company, which is already ISO13485 certified, will be obtaining approval for the IDx-DR from the United States Food and Drug Administration. A clinical trial is underway and conversations with the FDA are ongoing.

IDx is currently in discussions with several major healthcare device manufacturers and distributors with both domestic and international networks. The company hopes to conclude major distribution partnership arrangements this year.

“CE approval for IDx-DR is a major leap forward for improving healthcare efficiency,” said President Dr. Abramoff, “But we’re just getting started.”

SOURCE IDx LLC


Originally published at https://www.prnewswire.com

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