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

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.

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