FDA Clearance for Algorithm that Quantifies Coronary Artery Calcification

July 13, 2018  Source: MobiHealthNews 210

Kibbutz Shefayim from an Israel-based startup company named Zebra Medical Vision announced that it has successfully received FDA clearance for an algorithm, which could aid physicians to quantify a patient’s coronary artery calcification. By looking at the ECG-gated CT scan report, the algorithm can automatically calculate the calcification rate using the Agatston Coronary Artery Calcium Scoring method.

 Dr. Ran Balicer, the director of the Clalit Research Institute in Israel, said “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 [health maintenance organizations] such as Clalit.”

Even though the startup has various algorithms cleared for use in the EU, it is the first time for the company to receive FDA clearance. Zebra Medical Vision has an expertise in designing artificial intelligence outfits for medical imaging and radiology like Textray chest X-ray, which is the most comprehensive tool to date.

Elad Benjamin, the co-founder and CEO of Zebra Medical Vision, said “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.”

By Ddu