Nano-X Imaging receives FDA clearance for HealthCCSng V2.0

NANO-X IMAGING announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received 510(k) clearance from the U.S. Food and Drug Administration 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 and electronic medical records 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 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.