The HealthCCSng solution is said to analyse commonly ordered non-gated CT scans to quantify the CAC as an incidental finding and categorise the patients into three categories based on the extent of cardiac calcium detected
Zebra Medical Vision has secured eighth FDA clearance for its coronary artery calcium solution. (Credit: Zebra-Med)
Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cardiac solution called HealthCCSng.
The company stated that it is the eighth FDA clearance for its coronary artery calcium (CAC) solution, which is part of the company’s population health offering.
HealthCCSng, which is designed to reduce costs for the healthcare systems, enables clinicians to report findings and recommend preventative treatments before a coronary event takes place.
Developed by Zebra-Med, the solution is said to analyse commonly ordered non-gated CT scans to quantify the CAC as an incidental finding and categorise the patients into three categories based on the extent of cardiac calcium detected.
It helps clinicians to diagnose patients with CVD who have been previously undetected. The IDNs and commercial payers will also be actively manage and stratify their covered population health risk by deploying the FDA-cleared HealthCCSng.
Zebra Medical Vision CEO said: “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.
“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.”
Last month, Israel-based Nanox agreed to acquire Zebra Medical Vision in a deal valued at around $200m.
Zebra Medical offers imaging analytics platform, which will help healthcare institutions to detect patients at risk of disease and offer enhanced preventative treatment pathways to advance patient care.