iHealthScreen Inc. Announces UK Medicines and Healthcare Products Regulatory Agency (MHRA) Certification and registration for iPredict™ - Automated AI System for Early Diagnosis of DR, AMD, and Glaucoma

Earlier iHealthScreen received the CE certification for simultaneous diagnosis of DR, AMD, and glaucoma suspect as the first USA company

NEW YORK--(BUSINESS WIRE)--iPredict™ AI Eye Screening System provides fully automated diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results. 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.

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.

iPredict is indicated for use by healthcare providers in clinics, hospitals, or other healthcare facilities to automatically detect DR, AMD, and glaucoma suspects.

“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.

“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, the founder and CEO of the company.

The tool is now used in Australia, the United Arab Emirates and Bangladesh and already screened more than ten thousand people in clinical settings for diabetic retinopathy, age-related macular degeneration, and glaucoma.

iHealthScreen company is open to partnerships within its products. For more information: https://www.iHealthScreen.org