Zebra Medical Vision receives its first 510(k) clearance for coronary artery calcification algorithm

By Dave Muoio
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Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced that it has received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification.

From a ECG-gated computed tomography (CT) scan, the Coronary Calcium Scoring algorithm automatically calculates a calcification rating equivalent to those derived using the Agatston Coronary Artery Calcium Scoring method.

“Identification of high-risk individuals is key to prevention,” Dr. Ran Balicer, director of the Clalit Research Institute in Israel, said in a statement from the company. “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 [health maintenance organizations] such as Clalit.”

Zebra Medical Vision has a focus on designing artificial intelligence tools for medical imaging and radiology — for instance, the recently unveiled Textray chest X-ray research, which the company called “the most coprehensive AI research on chest X-rays to date” in June. This is the first FDA clearance for the startup, which currently has several of its algorithms cleared for use in the EU.

“This clearance will allow us to begin expanding our footprint in the US,” Elad Benjamin, cofounder and CEO of Zebra Medical Vision, said in a statement. “Following seven algorithms that have CE mark, it is the first of many to come, as we continue building our automated analytics engine.”

Also in June, the Israeli imaging company announced that it had raised $30 million in Series C funding from aMoon, Aurum Ventures, Johnson & Johnson Innovation JJDC, and Intermountain Healthcare, bringing its total financing to $50 million. Prior to this, Zebra had brought in $12 million in May 2016.