FDA permits AI-powered medical device to detect diabetic eye ailment
Category: #health  By Dhananjay Punekar  Date: 2018-04-12
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FDA permits AI-powered medical device to detect diabetic eye ailment

In what may be touted to be a highly victorious incidence in the medical devices industry, the U.S. FDA has approved the sale of an innovative medical equipment. Referred as IDx-DR, this device makes use of AI technology to detect the most common cause of vision loss witnessed among more than thirty million diabetics across the U.S.

The medical device is first of its kind to receive the nod of approval from the federal agency of the U.S. health department & human services. The product, which is manufactured by IDx LLC, offers a screening decision related to the loss of vision without the requirement of any physician for interpreting the eye images. Experts claim the product to be more useful for the doctors who interact on a regular basis with diabetics.

IDx-DR is likely to find applications in the detection of diabetic retinopathy, a medical condition during which the retina of the eye is damaged due to diabetes mellitus leading to blindness. The IDx-DR device makes use of AI system to examine the images of eye captured with the help of retinal camera. Incidentally, the system also informs the physician about the intensity of diabetic retinopathy in the patient.

In the clinical trials carried out by the FDA, IDx-DR was able to accurately determine the presence of more than mild diabetic retinopathy nearly 87.4% of the times in patients. The outcomes of the clinical trials for the diabetics proved that the medical instrument can detect patients who are not affected due to more than mild ailment nearly 89.5% of the times.

Malvina Eydelman, one of FDA officials, announced that the food & drug authority of the country will continue to facilitate access to safe and efficient digital health devices for the patients. As per reports, the review of IDx-DR was carried out by the FDA in accordance with the new regulations designed to speed up the marketing of some medical devices categorized under low and moderate risk types.



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Dhananjay Punekar

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Dhananjay Punekar

Dhananjay Punekar presently develops content for a slew of portals, including Market Size Forecasters and Algosonline. A post graduate in mathematics and business administration, he worked in Infosys BPO Limited prior to switching his professional genre. As a content wr...

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