iHealthScreen, maker of AI-enabled software for retinal imaging, has received 510(k) clearance from the FDA for its iPredict eye screening system that leverages AI to help providers determine if a patient is over 50 suffers from age-related macular degeneration.
The iPredict system detects AMD by using AI to analyze high-resolution images of a patient’s eyes taken with a color fundus camera. The test can be completed in five minutes and results are available in 60 seconds.
The company is currently in the process of raising funds for a $5 million pre-Series A round.
“This is a major milestone for iHealthScreen. iPredictTM eye disease diagnostic tools can help prevent blindness in millions and save insurers countless millions of dollars in healthcare costs. preventable,” said Dr. Alauddin Bhuiyan, founder and CEO of iHealthScreen in a statement.
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In 2019, 19.8 million people in the United States were living with some form of age-related macular degeneration, an increase of more than 2.75 times previous estimates, according to a study in JAMA Ophthalmology.
In 2021, iHealthScreen received CE certification for its iPredict system for the early diagnosis of diabetic retinopathy, glaucoma and age-related macular degeneration. A year later, the US-based company announced that it had won approval from the Therapeutic Goods Administration of Australian Health.
Another company using AI to detect AMD is Optlaunched earlier this month by Aegis Ventures And Northwell Holdings, the investment arm of the New York-based healthcare system. Optain uses AI-based retinal imaging to detect early signs of the disease using technology from Australian company Eyetelligence. The partners provided Optain with an initial investment of $12 million.