First AI Device to Detect Diabetic Retinopathy Now Approved (Download PDF)


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FDA (Federal Drug Agency) permitted marketing of IDx-DR for detection of diabetic retinopathy in adults, 1st medical device that uses artificial intelligence (AI) in this setting. Clinical trial included 900 patients w/diabetes from 10 primary care sites across U. S.

Image of Diabetic Retinopathy

Image of Diabetic Retinopathy

Image of Diabetic Retinopathy

What is Diabetic Retinopathy?

  • Diabetic retinopathy, most common cause of vision loss for people living w/diabetes, occurs when high levels of blood sugar lead to damage in blood vessels of retina, light-sensitive tissue in back of eye.
  • 87.4 % of time, IDx-DR could detect more-than-mild cases of diabetic retinopathy. It ruled out more-than-mild diabetic retinopathy 89.5 % of time.

Significance of IDx-DR

  • Early detection of retinopathy is imp. part of managing care for millions of people w/diabetes, yet many patients w/diabetes are not adequately screened for diabetic retinopathy since about 50 % of them do not see their eye doctor on yearly basis.
  • Patients w/positive results should be referred to eye care provider as soon as possible, for further evaluation & possible treatment.
  • Device was designed for assessment of diabetic retinopathy during routine visits, but should not be viewed as replacement for routine eye examinations at ages 40 & 60.
Image of Significance of IDx-DR

Image of Significance of IDx-DR

Image of Significance of IDx-DR

How Does IDx-DR Work?

IDx-DR uses algorithm that analyzes retinal images. If quality of retinal images is sufficient, IDx-DR will deliver one of two results:

  • “More than mild diabetic retinopathy detected: refer to eye care professional”

  • “Negative for more than mild diabetic retinopathy; re-screen in 12 months”

Who Should Not Use IDx-DR?

  • FDA noted that device is contraindicated in patients who have had eye surgery, laser treatment, or eye injections.

  • Patients should not get IDx-DR screening if they have floaters, macular edema, retinal vein occlusion, persistent vision loss, blurred vision, proliferative retinopathy, severe non-proliferative retinopathy, or radiation retinopathy.

  • IDx-DR should not be used in pregnant patients, as diabetic retinopathy can progress rapidly in these patients & device is not intended to evaluate rapidly progressive retinopathy.

- Published/Last Modified on: August 13, 2018

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