Nano-X Imaging has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HealthCCSng V2.0, an upgraded version of its artificial intelligence (AI) cardiac assessment solution.
The FDA clearance was granted to Nanox.AI, the deep-learning medical imaging analytics subsidiary of the Nasdaq-listed Nano-X Imaging. It allows Nano-X Imaging to advance its AI technology in cardiac risk evaluation.
The HealthCCSng V2.0 builds upon its predecessor, HealthCCSng, which, as per Nano-X Imaging, has already proven effective in identifying patients at high risk of coronary artery disease.
The upgraded solution continues to utilise medical imaging data from routine non-gated, non-contrast CT scans covering the entire heart of patients aged 30 to 85. It automatically measures coronary artery calcium (CAC), a primary indicator of future cardiovascular events.
The HealthCCSng V2.0 is said to integrate seamlessly with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, facilitating timely preventive care and generating significant revenue for cardiology departments.
The device aims to exploit the frequent use of CT scans in medical care, including lung cancer screening programmes, to detect coronary artery calcification opportunistically. Elevated CAC levels correlate with a substantially higher likelihood of cardiac events.
Key features of the upgraded HealthCCSng V2.0 include a new ‘Zero CAC Category’, which allows clinicians to easily differentiate between patients with zero and low CAC levels, with zero CAC indicating a very low risk of cardiac events. This new category supplements the existing ‘low’, ‘medium’, and ‘high’ CAC classifications.
The device also now provides numerical CAC scoring alongside the CAC category, enhancing the precision of cardiac risk assessments. Additionally, HealthCCSng V2.0 introduces configurable CAC category boundaries, enabling users to adjust the ranges for low, medium, and high CAC scores according to their needs.
Nano-X Imaging CEO Erez Meltzer said: “We are pleased to receive another regulatory clearance from the FDA for our AI cardiac solution, with new updates that reflect our commitment to providing healthcare professionals with the tools they need.
“The AI cardiac solution helps to bridge the divide between radiology and cardiology, two medical specialties that often use different terms and descriptions to assess imaging data, and catches patients who might otherwise fall through the cracks so that they can be directed to appropriate preventative healthcare.”
In June 2024, Nanox.AI integrated AI functionality into the Second Opinions online medical consultation platform. Provided by USARAD, a subsidiary of Nano-X Imaging, this platform connects patients with radiologists and other specialists for additional consultations.
The integration of three FDA 510(k)-cleared AI solutions from Nanox.AI is designed to enhance the early detection of chronic conditions in chest and abdominal CT scans.
