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

by MGN
May 26, 2023
in Health
Reading Time: 2 mins read
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iHealthScreen receives FDA 510(k) for AI-enabled eye screening system
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I Asked ChatGPT to Create Summer Outfits, and I'd Totally Wear These 6 Chic Ones

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iHealthScreen, maker of AI-enabled software program for retinal imaging, acquired 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 by utilizing AI to research high-resolution pictures of a affected person’s eyes taken with a coloration fundus digital camera. The check will 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 may also help stop blindness for tens of millions of individuals and save insurers numerous tens of millions of {dollars} in avoidable healthcare price,” 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 accordance with a research in JAMA Ophthalmology. 

In 2021, iHealthScreen acquired CE certification for its iPredict System for the early prognosis 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 supplied Optain with an preliminary seed funding of $12 million. 

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