FDA OKs use of algorithm to ID cardiac risk from CT scans

Zebra Medical Vision says it can find patients with high calcium scores based on standard images.

Zebra Medical Vision has received approval from the Food and Drug Administration for an algorithm that helps physicians calculate the risk for coronary artery disease from computed tomography scans.

The Israel-based company received approval from the federal agency to market the algorithm, which it says is able to do the calculations to estimate a patient’s risk for artery disease based on calcium scores, based on images from CT scans.

The algorithm is based on electrocardiogram (ECG) gating, which enables stop-motion imaging that acquires images only during specific parts of the cardiac cycle, typically during diastole when the heart is not moving.

Also See: FDA clears AI technology that evaluates echocardiograms

Zebra Medical Vision says the algorithm can be paired with the imaging technology to automatically calculate a patient’s Agatston equivalent coronary calcium score, which can provide estimates of coronary artery calcification detected by an unenhanced low-dose CT scan, which is routinely performed in patients undergoing cardiac CT.

Use of the Agatston test enables an early risk stratification for patients for coronary artery disease; those with high scores, exceeding 160 have an increased risk for major cardiac events, such as a heart attack. The score highly correlates with contrast-enhanced CT coronary angiography.

Coronary artery disease is a major cause of death in developed countries. It remains responsible for approximately one-third of all deaths of individuals older than 35 years old.

Numerous studies have shown that early detection and treatment of CAD can reduce the incidence of heart attacks in at-risk populations. Studies have also shown that coronary artery calcium score is useful for risk stratification of patients.

“Identification of high-risk individuals is key to prevention,” said Ran Balicer, Director of the Clalit Research Institute, which is the largest integrated healthcare payer and provider system in Israel, caring for more than 4 million people.

“Zebra’s algorithm could run on CT studies of the chest and potentially help identify people with cardiovascular risk sooner, allowing more effective treatment and overall reduction of adverse outcomes and healthcare costs for HMOs such as Clalit.”

“This clearance will allow us to begin expanding our footprint in the United States,” says Elad Benjamin, co-founder and CEO of Zebra Medical Vision. “Following seven algorithms that have CE mark, it is the first of many to come, as we continue building our automated analytics engine.”

Zebra Medical Vision has an imaging analytics platform to help healthcare organizations identify patients at risk of disease.

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