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

by | Jun 1, 2023 | Health Blog | 0 comments

Editor’s observe: This text has been up to date to replicate iHealthScreen has submitted however not but acquired 510(okay) clearance for iPredict.

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

The iPredict System screens for AMD through the use of AI to investigate high-resolution pictures of a affected person’s eyes taken with a shade fundus digicam. The check will be executed in 5 minutes, and outcomes can be found inside 60 seconds.  

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

“This can be a main milestone for iHealthScreen. iPredictTM eye illness diagnostic instruments may help forestall 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 mentioned in a press release. 

THE LARGER TREND

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 keeping with 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 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 know-how from the Australian firm Eyetelligence. The companions supplied Optain with an preliminary seed funding of $12 million. 



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