iHealthScreen Announces MHRA Certification and Registration for iPredict Automated AI System

iHealthScreen has received UK Medicines and Healthcare Products Regulatory Agency (MHRA) certification and registration for its iPredict AI Eye Screening System, which is used for the early diagnosis of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma.

iPredict’s MHRA/CE certification indications for use are 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.

If referable stage disease is detected for any of these conditions, the iPredict automated 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.

According to iHealthScreen, using the iPredict system, primary care and various specialty practices can 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 patient’s eyes have been captured using a color fundus camera and submitted to the iPredict AI System, the screening results are available in a fully automated report in less than 60 seconds. The entire test can easily and reliably be completed within 5 minutes.

“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 costs,” said Dr. Alauddin Bhuiyan, founder and CEO of the company.

The tool is now used in Australia, the United Arab Emirates, and Bangladesh and already screened more than 10,000 people in clinical settings for DR, AMD, and glaucoma.