Israeli machine-learning radiology firm Zebra Medical Vision said this week it won FDA 510(k) clearance for its Coronary Calcium Scoring algorithm.
The company said the algorithm is designed to automatically calculate a patient’s Agatston equivalent coronary calcium score from ECG gated CT scans to improve assessments of patients at risk for coronary artery disease.
“Identification of high-risk individuals is key to prevention 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,” Clalit Research Institute director Ran Balicer said in a prepared statement.
“This clearance will allow us to begin expanding our footprint in the US. Following seven algorithms that have CE mark, it is the first of many to come, as we continue building our automated analytics engine,” co-founder & CEO Elad Benjamin said in a press release.
Last month, Zebra Medical Vision said it raised $30 million in a Series C round of financing.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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