FDA approves IDx-DR diagnostic medical device for diabetic retinopathy.- IDx.

The FDA has permitted marketing of the IDx-DR, the first diagnostic medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. 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.

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.

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.

The device 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: more than mild diabetic retinopathy detected or negative for more than mild diabetic retinopathy.