iHealthScreen receives FDA 510(okay) for AI-enabled eye screening system

iHealthScreen, maker of AI-enabled software program for retinal imaging, obtained FDA 510(okay) clearance for its iPredict Eye Screening System that leverages AI to assist suppliers decide if a affected person over 50 has age-related macular degeneration. 

The iPredict System screens for AMD through the use of AI to research high-resolution photos of a affected person’s eyes taken with a colour fundus digicam. The check could be accomplished in 5 minutes, and outcomes can be found inside 60 seconds.  

The corporate is presently fundraising for a pre-Sequence A spherical of $5 million. 

“This can be a main milestone for iHealthScreen. iPredictTM eye illness diagnostic instruments may also help stop blindness for thousands and thousands of individuals and save insurers numerous thousands and thousands of {dollars} in avoidable healthcare price,” Dr. Alauddin Bhuiyan, founder and CEO of iHealthScreen mentioned in an announcement. 


In 2019, 19.8 million people within the U.S. lived with some type of age-related macular degeneration, a rise of greater than 2.75 instances earlier estimates, in response to a examine in JAMA Ophthalmology

In 2021, iHealthScreen obtained CE certification for its iPredict System for the early analysis of diabetic retinopathy, glaucoma and age-related macular degeneration. A 12 months later, the U.S.-based firm introduced it gained approval from Australian Well being’s Therapeutic Items Administration. 

One other firm using AI to detect AMD is Optain, launched earlier this month by Aegis Ventures and Northwell Holdings, the funding arm of the New York-based well being system. Optain makes use of AI-backed retinal imaging to catch early indicators of the illness using expertise from the Australian firm Eyetelligence. The companions offered Optain with an preliminary seed funding of $12 million. 


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