Nanox.AI’s HealthCCSng V2.0 Cleared for Coronary Artery Calcium Assessment

September 3, 2024—Nano-X Imaging Ltd. recently announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received FDA 510(k) clearance for its HealthCCSng V2.0 cardiac solution. Nano-X Imaging is an Israel-based medical imaging technology company.

According to the company, HealthCCSng V2.0 is the upgraded version of Nanox.AI’s HealthCCSng, which identifies patients at high risk of coronary artery disease by assessing coronary artery calcium (CAC).

As outlined in the press release, new features on HealthCCSng V2.0 include:

• Zero CAC Category. Added to the low, medium, and high CAC categories, this new category enables clinicians to easily distinguish between patients with zero and low CAC levels.
• Numerical CAC Scoring. This allows clinicians to fine tune cardiac risk assessments of patients.
• CAC Category Configuration. This enables users to adjust the lower and upper bounds for the low (1-99 Hounsfield units [HU] by default), medium (100-399 HU by default) and high (400+ HU by default) categories of CAC scores.

The company noted that the original HealthCCSng has been integrated with existing picture archiving and communication systems and electronic medical records systems to enable timely and appropriate preventive care. HealthCCSng utilizes medical imaging data from routine nongated, noncontrast CT scans that include the entire heart of adult patients—ages 30 to 85 years—to automatically measure CAC.

Nano-X Imaging stated that 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.

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, advised the company.