CE Certification For IPredict Automated AI System

iHealthScreen Inc. Announces CE Certification for iPredict^TM Automated AI System for Early Diagnosis of Diabetic Retinopathy (DR), Age Related Macular degeneration (AMD), and Glaucoma Suspect

iHealthScreen is the first company in the USA to receive a CE certification for simultaneous diagnosis of DR, AMD, and glaucoma suspect.

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^TM 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 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.

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 suspect.

iPredict achieved very high accuracy in the diagnosis of these diseases with referable and non-referable status. For disease diagnosis:

iPredict-DR achieved up to 98.48% accuracy with 97.32% sensitivity and 98.75% specificity for identification of referable DR.
iPredict-AMD achieved up to 99.2% accuracy with 98.9% sensitivity and 99.5% specificity for identification of referrable AMD.
iPredict-glaucoma achieved 89.67% accuracy with 83.33% sensitivity and 93.89% specificity for glaucoma suspect.

“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.

“By alerting patients and their physicians to the potential dangers ahead, we believe this screening tool could play a very important public health role.”

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

The company is currently in the final phase of clinical trials and working on FDA clearance for these indications and others.