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 through the use of AI to investigate high-resolution photos of a affected person’s eyes taken with a shade fundus digital camera. The check will be accomplished 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. 

“It is a main milestone for iHealthScreen. iPredictTM eye illness diagnostic instruments may help stop blindness for hundreds of thousands of individuals and save insurers numerous hundreds of thousands of {dollars} in avoidable healthcare value,” Dr. Alauddin Bhuiyan, founder and CEO of iHealthScreen mentioned in a press release. 


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

Crypto Lender Celsius Selects Fahrenheit’s Bid for Chapter Exit

A Complete Comparability for Startups