iHealthScreen has received Australian Health Therapeutic Goods Administration (TGA) approval for its iPredict AI eye screening system.

The automated AI system is intended for the early diagnosis of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results.

iHealthScreen is said to be the first US firm to win the CE mark, TGA approval and Abu Dhabi Health approval for simultaneous detection of the DR, AMD, and glaucoma suspects.

According to the company, the iPredict system enables primary care and specialty practices to accurately screen diabetic patients for DR, persons over 50 for AMD, and those with a family history of glaucoma or other risk factors for suspected glaucoma.

iHealthScreen founder and chief executive officer 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 system is designed to provide fully automated reports in less than 60 seconds, after high-resolution photos of the eyes captured using a colour fundus camera are submitted.

The system allows the entire test to be completed within 5 minutes.

iPredict is intended for use by healthcare providers in clinics, hospitals or other healthcare facilities for the detection of DR, AMD 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.”

In June last year, iHealthScreen received CE certification for its AI-based software tool iPredict System for early diagnosis of certain ophthalmic diseases.