Optomed announces the results from the prospective, multi-center clinical trial intended to assess its handheld fundus camera Aurora together with AEYE Health’s AI for autonomous detection of more than mild diabetic retinopathy, a blinding eye disease estimated to affect over 190 million people globally by the year 2030.
Optomed and AEYE Health previously announced their cooperation to introduce an AI-assisted fundus camera Aurora AEYE and conduct a clinical trial with the aim to receive U.S. FDA clearance for autonomous AI for retinal screening for more than mild diabetic retinopathy on 18th September 2020.
Among patients positive for more-than-mild diabetic retinopathy, the combined product, Aurora AEYE detected 91.9 percent (sensitivity), while patients without the eye disease were correctly identified 93.6 percent of the time (specificity). The observed imageability was over 99 percent.
Optomed’s CEO, Seppo Kopsala, commented: “Completing the clinical trial with such promising results is the first step of our plan to receive the U.S. FDA clearance for the AI-assisted fundus camera Aurora AEYE. The observed sensitivity and specificity and especially the high imageability achieved hold the promise of moving forward together with AEYE Health to introduce the first handheld AI fundus camera in the U.S. market.”
AEYE Health’s CEO, Zack Dvey-Aharon, Ph.D., comments: “We are thrilled that our AI exhibited such high efficacy on a portable camera and especially given the use of only a single image obtained per eye. We believe this achievement will truly revolutionize and democratize retinal screening. Optomed is a fantastic partner and we look forward to delivering on this promise.“
Source: Optomed Plc