The Australian Health Therapeutic Goods Administration (TGA) has granted approval to iHealthScreen’s iPredict automated AI eye screening system.
The AI system is designed for the early diagnosis of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect, including retinal imaging.
It enables primary care, as well as various speciality practices, to accurately test diabetic patients for DR, people over 50 for AMD, and people with a family history of glaucoma, or other risk factors, for suspected glaucoma.
The company claims to be the first US firm to win the CE mark, TGA approval, and Abu Dhabi Health approval for the detection of AMD, DR, and glaucoma suspect simultaneously.
iHealthScreen founder and CEO Dr Alauddin Bhuiyan said: “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.”
The iPredict AI eye screening system provides a fully automated report in less than 60 seconds, after the high-resolution images of the patient’s eyes are captured using a colour fundus camera.
iHealthScreen stated that the complete test can be carried out in under five minutes.
The device is intended for use by healthcare providers in hospitals, clinics, or other healthcare facilities for automatic detection of AMD, DR, and glaucoma suspect.
Icahn School of Medicine at Mount Sinai, New York Ophthalmology and Neuroscience professor Dr Theodore Smith said: “This technology could be particularly useful in identifying someone who has slipped across the boundary to progress into severity.”