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Eye disease AI screening system TGA-approved

The Therapeutic Goods Administration (TGA) has approved a new AI software system that can screen for three major eye diseases in primary care settings.

The iPredict System was cleared for Australian use in February as a Class IIa device, with its manufacturer iHealthScreen Inc also announcing CE certification for the European market.

According to the TGA’s public summary, the system can automatically screen people at risk of developing diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma.

An individual software application program or group of programs is used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote, telemedicine use.

“The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss,” the summary stated.

“A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop, or tablet computer.”

In a media release, iHealthScreen said the iPredict System would allow primary care and various specialty practices to accurately and efficiently screen diabetic patients for DR, people over 50 for AMD, and those with a family history of glaucoma or other risk factors for suspected glaucoma.

Once high-resolution images of the eye have been captured using a colour fundus camera and submitted to the system, the screening results are available in a fully automated report in less than 60 seconds. The entire test can be completed within five minutes.

iPredict’s CE certification indications for use as follows:

  • iPredict-DR can detect more than mild DR or vision threatening DR such as severe non-Proliferative DR, proliferative and diabetic macular EDEMA.
  • iPredict-AMD can detect referable AMD such as intermediate to late AMD and non-referable AMD such as early or none.
  • iPredict-glaucoma detects glaucoma suspects based on abnormal optic discs.

iHealthScreen said if referable stage disease is detected for any of these conditions, the iPredict report recommends a visit to an ophthalmologist for appropriate treatment. Otherwise, in accordance with standards of care, a follow up visit in one year is suggested.

“This technology could be particularly useful in identifying someone who has slipped across the boundary to progress into severity,” Dr Theodore Smith, Professor in Ophthalmology and Neuroscience at Icahn School of Medicine at Mount Sinai, New York, said.

Dr Alauddin Bhuiyan, founder and CEO of the company, added: “This is a major milestone for iHealthScreen. iPredict eye disease diagnostic tools will help prevent blindness for millions of people and save insurers countless millions of dollars in avoidable healthcare cost.”

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