FDA clears artificial intelligence tool for incidentally determining heart disease risk via CT
The U.S. Food and Drug Administration has cleared a new artificial intelligence solution to help physicians incidentally detect patients’ risk of heard disease via commonly ordered CT scans.
HealthCCSng is the eighth FDA-cleared product from Israel-based Zebra Medical Vision, which previously scored regulatory approval in Europe. The AI tool works by analyzing non-gated computed tomography images, helping to quantify coronary artery calcium and separate patients into three different risk categories.
Cardiovascular disease is one of the leading causes of death worldwide, Zebra Medical noted Monday. Yet upward of 50% of patients don’t know they have CVD until after that first heart attack. The firm hopes to help clinicians catch heart concerns earlier, noting that patients in the highest coronary artery calcium scoring categories are 20 times likelier to suffer a cardiac event. However, gated CAC scans can prove costly and are often not covered by insurance.
Fellow Israel-based imaging firm Nanox recently revealed plans to acquire Zebra Medical Vision for $200 million and touted the FDA clearance in its own Sept. 27 announcement.
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Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.