Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Diabetes

FDA approves first AI diagnostic device

Marketing of a device with artificial intelligence to help screen patients with mild diabetic retinopathy has been approved by the US Food and Drug Administration.

A screening device that uses artificial intelligence (AI) to eliminate the need for a clinician to interpret results has been authorised for use for the first time in the United States.

The US Food and Drug Administration has approved the marketing of a device that uses AI to determine whether a person with diabetes has more than mild diabetic retinopathy. It is the first time such a device has been approved and opens up the possibility of screening being done by healthcare providers who are not usually involved in eye care.

Digital images of the patient’s eyes are taken using a retinal camera and are then uploaded to a cloud server where the IDx-DR AI is installed. If the images are of sufficient quality, the software will produce one of two responses — that the patient has more than mild diabetic retinopathy, in which case they need to be referred to an eye care professional, or that they are negative for this but should be rescreened in 12 months.

Around half of people with diabetes in the United States do not see a specialist eye doctor each year, but the IDx-DR approach could allow them to be screened when seeing their primary care doctor, or potentially by other healthcare professionals.

In a 900-person trial, the software was found to correctly identify the presence of more than mild retinopathy 87.4% of the time, and patients who did not have more than mild retinopathy 89.5% of the time. The method is not suitable for some patients, including pregnant women or those with a history of eye surgery or injections.

More than 30 million people in the United States have diabetes and diabetic retinopathy is the most common cause of visions loss in this group.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204677

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Pharmacy Registration Assessment Questions 2

    Pharmacy Registration Assessment Questions 2

    Pharmacy Registration Assessment Questions 2 features more than 400 entirely new, closed book and calculation questions. It can be used in conjunction with the previous volume or on its own. All questions are in line with current GPhC guidance, enabling you to prepare for the pharmaceutical pre-registration exam with confidence.

    £35.00Buy now
  • Principles of Good Clinical Practice

    Principles of Good Clinical Practice

    A one-stop source for the proper conduct of clinical trials. Essential information on clinical trial design and pharmacovigilance.

    £49.00Buy now
  • Integrated Pharmacy Case Studies

    Integrated Pharmacy Case Studies

    Over 90 case studies based on real life patient-care scenarios. Each case includes learning outcomes and references.

    £47.00Buy now
  • Pharmacy OSCEs

    Pharmacy OSCEs

    The only pharmacy-specific OSCE revision guide. This easy-to-use book covers the key competencies that will be tested in your exams.

    £25.00Buy now
  • Popular Medicines

    Popular Medicines

    An illustrated history of some of the most popular branded medicines. Includes colourful historical adverts and details of the medicine's formula and intended purpose.

    £22.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Photo of a person's eye displaying diabetic retinopathy

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.