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Zebra Medical Vision Announces FDA 510(k) Clearance of Its Coronary Calcium Algorithm

July 11, 2018

SHEFAYIM, Israel--(BUSINESS WIRE)--Jul 11, 2018--Zebra Medical Vision ( http://zebra-med.com/ ) announces today it has received 510(k) clearance for its Coronary Calcium Scoring algorithm. The algorithm, capable of automatically calculating a patient’s Agatston equivalent coronary calcium score from ECG gated CT scan, provides physicians with important data used in the assessment of the risk for coronary artery disease.

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Zebra Medical Vision announces FDA 510(k) clearance of its Coronary Calcium algorithm (Photo: Business Wire)

Coronary artery disease (CAD) is a major cause of death in developed countries. It remains responsible for approximately one-third of all deaths of individuals aged over 35 years old. According to estimates, nearly one-half of men and one-third of women over 40 years old will develop some symptoms of CAD in the United States. 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 Prof Ran Balicer, Director of the Clalit Research Institute. Clalit is the largest integrated healthcare payer/provider system in Israel, caring for over four 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 US”, 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.”

About Zebra Medical Vision

Zebra Medical Vision uses deep learning to create and provide next generation products and services to the healthcare industry. Its Imaging Analytics Platform gives healthcare institutions tools to potentially identify patients at risk of disease, allowing them to improve patient care. Headquartered in Kibbutz Shefayim Israel, the Company was founded in 2014 by Co-Founders Eyal Toledano, Eyal Gura, and Elad Benjamin and funded by aMoon, Aurum, Intermountain Investment Fund, Johnson & Johnson Innovation JJDC Inc, OurCrowd, Qure and Dolby Ventures. For more information visit www.zebra-med.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180711005368/en/

CONTACT: Alona Stein

Blonde 2.0 for Zebra Medical Vision

alona@blonde20.com

KEYWORD: UNITED STATES NORTH AMERICA MIDDLE EAST ISRAEL

INDUSTRY KEYWORD: TECHNOLOGY DATA MANAGEMENT HEALTH CARDIOLOGY MEDICAL DEVICES FDA

SOURCE: Zebra Medical Vision

Copyright Business Wire 2018.

PUB: 07/11/2018 07:30 AM/DISC: 07/11/2018 07:30 AM

http://www.businesswire.com/news/home/20180711005368/en

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