iHealthScreen Completed Prospective Trial of AI-Based Tool for Age-Related Macular Degeneration (AMD) Screening and Submitting the Results to FDA for 510K Clearance

Prospective Study Earlier Presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and Selected for Panel Discussion as an Outstanding work.

• First prospective clinical study on AI and color retinal image-based early diagnosis of AMD in outpatient settings and first such submission to FDA.
• Study design reviewed with FDA at a pre-submission meeting to ensure its appropriateness and adequacy.
• Selected for the AAO 2020 panel discussion as one of the outstanding works of the conference.
• Initial results showed that the AMD screening tools achieved above 88% accuracy.
• The Study was funded by an NIH SBIR grant of $1.8M.

NEW YORK--(BUSINESS WIRE)--iHealthScreen Inc. completed a prospective study for early diagnosis of AMD in primary care settings. The initial clinical trial results show adequate accuracy for FDA clearance. The study was funded by NIH SBIR grants and completed with the collaboration of the New York Eye and Ear Infirmary at Mount Sinai.

AMD, with no early signs or symptoms, is a leading cause of adult blindness in the developed world. Early detection can enable preventative measures in time to reduce the incidence of AMD. Currently, AMD diagnosis has been limited to retinal examination by an ophthalmologist. AMD cases in the U.S. are expected to grow from 2.1 million to 5.4 million in the next ten years, and there is an increasing need for large-scale screening and identification of individuals who are at risk of developing late AMD. iHealthScreen’s AI-based tool can facilitate this screening and help prevention of late AMD, i.e., blindness.

In an interview, Dr. Bhuiyan spoke about the study and the findings: “We are encouraged by the results and believe that the new AI-based technology can diagnose early AMD in primary care settings, which enables the timely preventative measures by ophthalmologists and prevent this deterioration of vision. We want to express our sincerest thanks to the participants and professional staff who were involved in this clinical trial and gathered the data.”

“These results speak to the feasibility of this approach,” said Theodore Smith, M.D., Ph.D., Trial’s Principal-investigator and Professor at Icahn School of Medicine at Mount Sinai. “I believe that the ease of use of iHealthScreen’s AI tool will contribute to its adoption in the wider primary care community.”

iHealthScreen is in the final stage of submitting the results to FDA for 510K clearance.

About iHealthScreen

iHealthScreen is a private, clinical-stage, medical diagnostic/device company. iHealthScreen has developed iPredict, an AI and telemedicine-based HIPAA compliant platform for automated screening and prediction of individuals at risk of developing late age-related AMD, diabetic retinopathy (DR), glaucoma, cardiovascular heart disease, and stroke.