AI-powered AMD screening tool receives FDA clearance
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The FDA has given 510(k) clearance to iHealthScreen’s iPredict Eye Screening System, an AI-powered screening tool for age-related macular degeneration in patients aged 50 years and older, according to a company press release.
The system’s software analyzes a patient’s eyes through high-resolution images taken with a color fundus camera, conducting an AMD screening within 5 minutes and providing results within 60 seconds.
In the release, iHealthScreen CEO Alauddin Bhuiyan, PhD, called the FDA’s 510(k) clearance a “major milestone,” paving the way for the iPredict system to “help prevent blindness for millions of people and save insurers countless millions of dollars in avoidable health care cost.”
In the release, iHealthScreen said it is now raising capital for a pre-Series A funding round of $5 million.
The iPredict system gained CE certification in Europe in 2021 and approval from Australia’s Therapeutic Goods Administration in 2022.
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