Israel’s Zebra gets FDA nod for product that detects coronary calcium

Approval will allow the startup to market its AI-based algorithm in the US, to help physicians diagnose heart disease

Shoshanna Solomon is The Times of Israel's Startups and Business reporter

Zebra's Medical Vision's scan analysis technology in action (Courtesy)
Zebra's Medical Vision's scan analysis technology in action (Courtesy)

Zebra Medical Vision, an Israeli startup that uses machine learning technology to read and analyze data from CT and X-ray scans, said it has received a nod from the US Food and Drug Administration that will allow the firm to market its product in the US, to help physicians detect the buildup of calcium in coronary arteries, which serves as a measure of heart disease risk.

Zebra’s AI-based automated coronary calcium detection product is capable of automatically calculating a patient’s coronary calcium score from CT scans, providing physicians with important data that enables them to assess the risk of coronary artery disease, Zebra said.

A coronary calcium scan measures the amount of calcium in the walls of coronary arteries. Overview. Calcification is a sign of atherosclerosis, coronary heart disease, or coronary microvascular disease.

The approval is the first Zebra has received from the FDA and “one of the first ones for AI” in healthcare imaging, Eyal Gura, the co-founder and chairman of Zebra said by email.

Coronary artery disease (CAD) is the most common type of heart disease and a major cause of death in the US, both in men and women, according to the US National Library of Medicine.

A general view of the operating theater. (photo credit: Nati Shohat/Flash90)
Illustrative photo of an operating room. (Nati Shohat/Flash90)

The disease occurs when the arteries that supply blood to the heart harden and narrow, due to the buildup of cholesterol and other materials on the inner walls of the arteries. As a result, the heart muscle can’t get the blood or oxygen it needs.

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.

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 using a coronary artery calcium score is useful to assess risk in patients, Zebra said in a statement.

“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 4 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”, said Elad Benjamin, Co-Founder and CEO of Zebra Medical Vision in a statement.

The company needs to get regulatory approvals for each of its products and their applications to the various diseases in the respective markets they want to target. Seven of the company’s algorithms have already received the European CE regulatory mark.

“It is the first of many to come, as we continue building our automated analytics engine,” Benjamin said.

The company was founded in 2014 by co-founders Eyal Toledano, Gura, and Benjamin.  It is funded by the venture firm aMoon, Aurum, Intermountain Investment Fund, Johnson & Johnson Innovation JJDC Inc, OurCrowd, Clalit, Qure and Dolby Ventures.

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