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Zebra Medical Vision on Monday announced that it received FDA 510(k) clearance for HealthCCSng, an artificial intelligence (AI)-based coronary artery calcium (CAC) solution that allows clinicians to report findings and recommend preventative treatments before a coronary event occurs. CEO Zohar Elhanani said this new FDA nod for the company will enable "broader adoption of imaging AI as an integral part of value-based care."
According to Zebra-Med, CAC scoring is typically attained on a cardiac-gated scan, subjecting patients to additional cost and radiation exposure, and is usually not covered by insurance companies. However, the HealthCCSng solution analyses commonly ordered non-gated computerised tomography scans, which enables CAC quantification as an incidental finding and categorises patients into three categories based on the extent of cardiac calcium detected.
The solution, which is also CE-marked, "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," Zebra-Med stated.
The company is in the process of being acquired by medical imaging firm Nanox for up to $200 million. Elhanani noted that Zebra-Med's "population health solutions have already demonstrated great value in identifying patients at risk for major osteoporotic fractures…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."
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