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Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium
HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with
About this update from Nano-x Imaging Ltd
[{"type":"text","content":"HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output Marks second FDA 510(k) clearance of HealthCCSng product PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthCCSng V2.0. HealthCCSng V2.0 is the upgraded version of Nanox.AI’s cardiac solution, HealthCCSng, which has already shown tangible results in several healthcare systems, identifying patients at high risk of coronary artery disease while driving significant revenue to cardiology departments. It has also been seamlessly integrated with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, and enabled timely and appropriate preventive care. HealthCCSng utilizes medical imaging data from routine non-gated, non-contrast CT scans that include the entire heart of adult patients of ages 30-85 to automatically measure coronary artery calcium (CAC), which is the number one risk predictor for a future cardiovascular event. The product aims to leverage the high utilization of CT scans in the medical care environment, including lung cancer screening programs, to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. Patients with the highest category of CAC levels are over 13 times more likely to suffer a cardiac event. The device output is available to radiologists as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinical assessment by cardiologists, general practitioners and other medical professionals. HealthCCSng V2.0 introduces the following features that improve its ability to inform physicians and help them conduct the most appropriate risk assessment and subsequent preventative healthcare for patients: Zero CAC Category: HealthCCSng now enables clinicians to easily distinguish between patients with zero and low CAC levels. CAC levels of zero are associated with very low r...