iHealthScreen submits AI-enabled eye screening system for 510(k) clearance

Editor’s note: This article has been updated to reflect iHealthScreen has submitted but not yet received 510(k) clearance for iPredict.

iHealthScreen, maker of AI-enabled software for retinal imaging, has submitted its iPredict Eye Screening System, which leverages AI to help providers determine if a patient over 50 has age-related macular degeneration, for FDA 510(k) clearance.

The iPredict System screens for AMD by using AI to analyze high-resolution images of a patient’s eyes taken with a color fundus camera. The test can be done in five minutes, and results are available within 60 seconds.  

The company is currently fundraising for a pre-Series A round of $5 million. 

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

THE LARGER TREND

In 2019, 19.8 million individuals in the U.S. lived with some form of age-related macular degeneration, an increase of more than 2.75 times previous estimates, according to a study in JAMA Ophthalmology. 

In 2021, iHealthScreen received CE certification for its iPredict System for the early diagnosis of diabetic retinopathy, glaucoma and age-related macular degeneration. A year later, the U.S.-based company announced it gained approval from Australian Health’s Therapeutic Goods Administration. 

Another company utilizing AI to detect AMD is Optain, launched earlier this month by Aegis Ventures and Northwell Holdings, the investment arm of the New York-based health system. Optain uses AI-backed retinal imaging to catch early signs of the disease utilizing technology from the Australian company Eyetelligence. The partners provided Optain with an initial seed investment of $12 million.