Zebra Medical Vision Secures 8th FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

Rhea-AI Summary

Zebra Medical Vision has announced its eighth FDA 510(k) clearance for the HealthCCSng solution, designed to quantify coronary artery calcium (CAC) in existing non-gated CT scans to identify patients at risk for cardiovascular disease. This innovation aims to facilitate early diagnosis and treatment, thereby reducing healthcare costs. Zebra-Med's collaboration with Nanox is expected to enhance its AI capabilities and reach, supporting population health management and preventative care. The company emphasizes its commitment to improving healthcare outcomes through advanced imaging technologies.

Positive

• Achieved eighth FDA 510(k) clearance for the HealthCCSng solution.
• Enables early diagnosis of cardiovascular disease and promotes preventative care.
• Partnership with Nanox expected to expand AI capabilities and healthcare impact.

Negative

• None.

This latest milestone helps Zebra-Med expand its mission of screening populations at scale with its AI-based solutions, promoting early and preventative healthcare treatment. The CAC solution analyzes already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease.

"Zebra-Med’s population health solutions have already demonstrated great value in identifying patients at risk for major osteoporotic fractures. The company remains firmly committed to its robust product roadmap, which is designed to advance population health and preventative care...the implementation of Zebra-Med’s AI solutions with Nanox’s technology can help impact millions of lives globally, while significantly reducing cost of care."

SHEFAYIM, Israel--(BUSINESS WIRE)-- Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its eighth FDA 510(k) clearance for its cardiac solution, "HealthCCSng" which has already received a CE mark. The CAC solution will empower clinicians to report findings and recommend preventative treatments before a coronary event occurs, subsequently saving lives while lowering costs for the healthcare systems. Last month Zebra-Med announced it has entered into an agreement to be acquired by Nanox (NASDAQ: NNOX), an innovative medical imaging company. This agreement, once consummated, puts Zebra-Med on track to expand its mission of helping to diagnose populations at scale with its AI-based solutions, enabling IDNs and commercial payers to detect and treat patients at risk for chronic conditions while accurately adjusting their covered population risk.

Zebra Medical Vision secures 8th FDA clearance for its Coronary Artery Calcium (CAC) solution as part of its population health offering (Photo: Zebra-Med)

Approximately 90% of the annual $3.5 Trillion healthcare spending is allocated towards chronic disease management. Cardiovascular disease (CVD) leads all chronic diseases with the highest mortality in the world, with many cases discovered far too late. Up to 50 percent of patients discover they suffer from CVD only with their first heart attack. CAC scoring is the strongest predictor of future cardiac events, with patients in the highest score category being over 20 times more likely to suffer a cardiac event. Moreover, many studies show clear correlation between coronary artery calcium detected and severity of disease. Typically, CAC scoring may be attained on a cardiac-gated scan which subjects patients to additional cost and radiation exposure, and is typically not covered by insurance companies.

The HealthCCSng solution developed by Zebra-Med analyzes commonly ordered non-gated CT scans, which enables the quantification of the Coronary Artery Calcium (CAC) as an incidental finding and categorizes the patients into three categories, based on extent of cardiac calcium detected. The solution supports clinicians in diagnosing patients with CVD who were previously undetected, while stratifying such patients so that they can get the appropriate preventative cardiac care and treatment. By implementing the FDA-cleared HealthCCSng, IDNs and commercial payers can actively manage and stratify their covered population health risk, while significantly reducing cost of care through early intervention. As a result, patients can be placed on relevant care pathways to prevent or mitigate the chance of a future incident by detecting early signs of disease and estimating the likelihood of future cardiovascular events.

"This new milestone shows the FDA’s trust in our work, enabling broader adoption of imaging AI as an integral part of value-based care," says Zohar Elhanani, CEO of Zebra Medical Vision. "Zebra-Med’s population health solutions have already demonstrated great value in identifying patients at risk for major osteoporotic fractures. The company remains firmly committed to its robust product roadmap, which is designed to advance population health and preventative care. I believe that our expected collaboration with Nanox, and the implementation of our AI solutions with Nanox’s technology can help impact millions of lives globally, while significantly reducing cost of care."

About Zebra Medical Vision
Zebra Medical Vision’s medical imaging AI solutions empower healthcare systems and payers to identify patients at risk of having chronic disease, allowing them to fill treatment gaps and initiate new preventative care pathways. Zebra Medical’s solutions provide for more accurate risk-adjustment, timely intervention, and optimization of health system service quality and resources, while significantly reducing the associated costs. Analyzing millions of clinical images in real time, the Zebra AI-based solutions detect various medical indications alerting relevant healthcare stakeholders triggering new care pathways. Zebra Medical Vision’s solutions integrate into existing radiology workflows, including primary care physicians and specialists in cardiology, bone health and others.

Website: https://www.zebra-med.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210927005367/en/

Alona Stein

ReBlonde for Zebra Medical Vision

alona@reblonde.com

Source: Zebra Medical Vision

FAQ

What is Zebra Medical Vision's latest achievement?

Zebra Medical Vision has received its eighth FDA 510(k) clearance for its HealthCCSng solution.

How does the HealthCCSng solution impact patient care?

The HealthCCSng solution enables early detection of coronary artery calcium, facilitating timely preventative treatment for cardiovascular disease.

What is the role of Nanox in Zebra Medical Vision's future?

Nanox's collaboration with Zebra Medical Vision is expected to enhance AI-driven healthcare solutions and improve population health management.

What is the significance of CAC scoring in cardiovascular health?

CAC scoring is a strong predictor of future cardiac events, enabling early intervention to prevent severe outcomes.