On the heels of last month’s revelation that it will be acquired by Nanox, Israel-based medical imaging analytics company Zebra Medical Vision announces that it has received U.S. FDA 510(k) clearance for its coronary artery calcium (CAC) technology, HealthCCSng. This technology, which has already received the European CE mark, will enable clinicians to report findings and recommend preventative treatments before a coronary event occurs, according to Zebra Medical officials.
Moreover, the HealthCCSng technology analyzes commonly ordered non-gated CT scans, which facilitates the quantification of 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 cardiovascular disease 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, integrated delivery networks 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”
He adds, “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.”
