Editor’s be aware: This text has been up to date to mirror 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 research high-resolution photographs of a affected person’s eyes taken with a colour fundus digicam. The check will be achieved in 5 minutes, and outcomes can be found inside 60 seconds.
The corporate is at the moment fundraising for a pre-Collection A spherical of $5 million.
“This can be a main milestone for iHealthScreen. iPredictTM eye illness diagnostic instruments might help forestall 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 stated in an announcement.
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 line 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 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 supplied Optain with an preliminary seed funding of $12 million.