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


iHealthScreen, maker of AI-enabled software program for retinal imaging, acquired FDA 510(ok) 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 by utilizing AI to investigate high-resolution photos of a affected person’s eyes taken with a coloration fundus digital camera. The check may 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. 

“It is a main milestone for iHealthScreen. iPredictTM eye illness diagnostic instruments can assist stop blindness for tens of millions of individuals and save insurers numerous tens of millions of {dollars} in avoidable healthcare value,” Dr. Alauddin Bhuiyan, founder and CEO of iHealthScreen stated 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 occasions earlier estimates, based on a examine in JAMA Ophthalmology

In 2021, iHealthScreen acquired CE certification for its iPredict System for the early analysis of diabetic retinopathy, glaucoma and age-related macular degeneration. A yr 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 supplied Optain with an preliminary seed funding of $12 million. 

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