HealthCCSng

by Nano-X AI  · Based in Israel → — Empowering physicians in the assessment of coronary artery calcium from routine CT scans.
Cardiology Radiology

Not publicly available
Regulatory Status Disclosed

Overview

HealthCCSng by Nano-X AI is an FDA-cleared, AI-powered software solution designed to analyze routine non-gated, non-contrast chest CT scans. It automatically detects, quantifies, and categorizes coronary artery calcification (CAC), a key indicator of coronary artery disease. The tool helps clinicians identify asymptomatic patients at risk of cardiovascular events, facilitating earlier intervention and preventive care pathways. HealthCCSng V2.0, the upgraded version, introduces advanced features such as ‘zero calcium’ categorization, numerical CAC scoring, and customizable CAC category configuration. It seamlessly integrates with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Record (EMR) systems, providing valuable clinical insights directly within the radiologist’s workflow. The solution supports Current Procedural Terminology (CPT®) codes 0721T and 0722T for service reimbursement.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Analyzes non-contrast, non-ECG gated chest CT scans
  • Automatically detects and quantifies coronary artery calcification (CAC)
  • Categorizes studies into 'zero', 'low', 'moderate', and 'severe' CAC categories
  • Generates a numerical calcium score
  • Provides visualization of calcified plaques within coronary arteries
  • Seamless integration with PACS and EMR systems
  • Automated workflow for results without human intervention
  • Customizable CAC category configuration
  • Supports CPT Code III (0721T & 0722T) for service reimbursement
  • Device output available to radiologists as part of their standard workflow

Use Cases

  • Opportunistic screening for coronary artery disease from routine chest CT scans (e.g., lung cancer screening programs)
  • Early identification of patients at risk of cardiovascular events
  • Directing at-risk patients to appropriate preventative cardiac care and treatment pathways
  • Adding clinical value to radiology reports with numerical CAC scoring
  • Improving patient outcomes and potentially generating revenue for healthcare systems

What Physicians Need to Know

Cardiac CT/MRI Analysis
HealthCCSng is an FDA-cleared and CE-marked AI solution that analyzes routine non-gated, non-contrast chest CT scans to automatically quantify and analyze Coronary Artery Calcification (CAC). It does not require dedicated cardiac-gated scans.
Coronary Artery Assessment
The core functionality of HealthCCSng is the automated detection and estimation of coronary artery calcium (CAC). It categorizes patients into low, moderate, and severe CAC levels. Version 2.0 introduces numerical CAC scoring and a 'zero CAC' category, allowing for more refined cardiac risk assessments.
Heart Failure Risk Prediction
By identifying and quantifying Coronary Artery Calcification (CAC), HealthCCSng helps to detect hidden cardiovascular risks. CAC is a strong predictor of future cardiac events, including those that can lead to heart failure, enabling earlier intervention and preventive care.
Cardiac Monitoring Integration
HealthCCSng is designed for seamless integration with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems, facilitating its incorporation into standard clinical workflows.
Real-Time Alert Capability
The device output, including CAC categories and numerical scores, is available to radiologists as part of their standard workflow. A list of studies with successful algorithm analysis is also available for further clinical assessment by cardiologists and general practitioners, enabling timely direction to appropriate care pathways.
Physician Tip

HealthCCSng offers a valuable tool for opportunistic screening of cardiovascular disease risk by leveraging routine non-cardiac CT scans. Physicians should consider integrating this AI solution to identify patients with previously undetected coronary artery calcification, enabling early intervention and personalized preventive care pathways. The numerical CAC scoring and 'zero CAC' category in V2.0 provide enhanced granularity for risk stratification. It's particularly useful for patients undergoing chest CTs for other indications, as it can uncover incidental findings of cardiac risk without additional radiation or cost.

HealthCCSng is built for seamless integration into existing healthcare IT infrastructure. It connects with Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems, ensuring that the AI-generated CAC assessments are readily accessible within the radiologist's workflow and for subsequent clinical review by other medical professionals. This integration streamlines the process of identifying and managing at-risk patients.

Details

Category Cardiology AI
Pricing Not publicly available — Contact vendor for details
DeploymentCloud-based, integrates with PACS and EMR systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

HealthCCSng V2.0 received 510(k) clearance (K241440) from the U.S. FDA on August 21, 2024. The original HealthCCSng also had 510(k) clearance (K210085).

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

HealthCCSng, an AI-powered solution by Nanox.AI, is designed to detect and quantify coronary artery calcification (CAC) from routine chest CT scans, aiming to identify patients at risk of cardiovascular events. The software has received FDA 510(k) clearance and has been integrated into existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems. Physicians and studies highlight its potential for early risk identification and preventive cardiac care.

Overall: Positive

Strengths

  • Identifies previously undetected cardiovascular risks from routine CT scans.
  • Aids in early risk identification and prevention of cardiac events.
  • Integrates seamlessly with existing PACS and EMR systems.
  • Provides automated numerical CAC scoring and customizable CAC category bounds.
  • Helps bridge the divide between radiology and cardiology by providing a common assessment tool.
  • FDA-cleared and CE marked.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra regarding HealthCCSng itself.
  • Some general negative sentiment exists around the company Nanox (NNOX) stock performance.
  • General concerns about the legitimacy and review processes on platforms like Capterra and G2 were noted, but not specific to HealthCCSng.

Based on reviews from: Nanox.AI's HealthCCSng AI Solution Reveals ~60% of Patients in Study had Previously Undetected Risk of a Cardiovascular Event from Routine Chest CTs, accessdata.fda.gov, Medical Product Outsourcing, Stock Titan, Diagnostic Imaging

Last updated: 2026-07-18

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Medical Product Outsourcing
FDA Clears Nanox.AI's Coronary Artery Assessment Tech
Nanox.AI, a subsidiary of NANO-X Imaging Ltd., received FDA 510(k) clearance for HealthCCSng V2.0, an upgraded cardiac assessment solution. This version introduces additional 'zero calcium' categorization and generates a numerical calcium score to better identify patients at high risk of coronary artery disease.
2024-09
GlobeNewswire
Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium
NANO-X IMAGING LTD announced that its Nanox.AI subsidiary received FDA 510(k) clearance for HealthCCSng V2.0, an enhanced AI cardiac solution. This version improves the assessment of coronary artery calcium (CAC) by providing a zero CAC category and numerical scoring, aiding in early detection of coronary artery disease.
2024-08
AuntMinnie
FDA clears updated software by Nanox.AI
The U.S. Food and Drug Administration (FDA) cleared an updated version of Nanox.AI's HealthCCSng AI algorithm, HealthCCSng V2.0, for identifying patients at risk of coronary artery disease. The new features include a 'Zero CAC Category' and 'Numerical CAC Scoring' to enhance cardiac risk assessments.
2024-08
Diagnostic Imaging
FDA Clears Updated AI Software for CT-Based Coronary Artery Calcium Assessment
The FDA granted 510(k) clearance for HealthCCSng V2.0 software, which facilitates automated assessments of coronary artery calcium (CAC) scoring from non-contrast CT scans. Key features include numerical CAC scoring, a new zero CAC category, and customization of CAC scoring categories.
2024-08
BioWorld
Nanox software cleared for coronary artery calcification measurement
Nanox.AI's HealthCCSng V2.0, an AI cardiac solution, received FDA clearance, significantly enhancing the detection of coronary artery calcification. The software helps bridge the gap between radiology and cardiology by quantifying and analyzing CAC levels from CT scans.
2024-08
JMIR Preprints
AI Empowering Early Detection Of CAD Patients For Improved Cardiac Care: Implementation
Nanox.AI's HealthCCSng, an AI-based solution, identifies coronary artery calcium (CAC) categories in patients undergoing non-cardiac chest CT exams. A pilot implementation at Einstein Medical Center demonstrated significant clinical and economic benefits by enabling early detection and management of CAD.
2024-09
PMC - NIH
Artificial Intelligence in Coronary Artery Calcium Scoring
This article discusses the role of AI in coronary artery calcium scoring, highlighting HealthCCSng by Nanox AI as a commercially available system for coronary calcium quantification and categorization. It emphasizes the importance of automated CACS for early diagnosis and reduction of cardiovascular events.
2024-06
Stock Titan
New Clinical Study Data, Featuring Nanox.AI Cardiac Solution to Be Presented at SCCT 2026
Nanox Imaging Ltd. announced that new clinical data on its Nanox.AI cardiac solution, HealthCCSng, will be presented at the 21st Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT) in July 2026. The presentations will include initial findings from the multi-site AI INFORM trial.
2026-07

Videos

Product demos, reviews, and walkthroughs for HealthCCSng.

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Frequently Asked Questions

HealthCCSng is designed for seamless integration with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems. It automatically analyzes routine non-cardiac-gated CT scans to detect and categorize coronary artery calcification (CAC), providing valuable insights directly within the radiologist's standard workflow.
HealthCCSng is an FDA-cleared and CE marked medical device, with its V2.0 version also having received FDA 510(k) clearance. It adheres to stringent regulatory standards, employing robust encryption and access controls to ensure full HIPAA compliance and patient data privacy.
While highly effective in detecting coronary artery calcification, AI systems like HealthCCSng are reliant on the quality and diversity of their training data, which can lead to potential biases or inaccuracies for underrepresented demographic groups or rare conditions. It is intended as a decision support tool, complementing, not replacing, the nuanced clinical judgment of a physician.
HealthCCSng distinguishes itself by automatically detecting and categorizing coronary artery calcification from routine non-cardiac-gated CT scans, offering an opportunistic screening approach for cardiovascular risk. Other AI solutions in cardiology may focus on different areas such as ECG interpretation, cardiac MRI analysis, or risk prediction for various cardiac conditions.
HealthCCSng has obtained CPT Code III (0721T & 0722T) for reimbursement, providing a pathway for billing for its service. While specific pricing models were not detailed, AI diagnostics in cardiology have shown potential for higher reimbursement rates compared to non-AI counterparts, though the overall reimbursement landscape for AI is still evolving.
AI systems are susceptible to bias if trained on non-representative datasets, potentially leading to unequal care across different demographic groups. HealthCCSng is developed using diverse datasets and employs rigorous validation processes to identify and mitigate algorithmic bias, aiming for equitable performance across all patient populations.
Successful AI deployment, including HealthCCSng, requires comprehensive training and ongoing technical support to ensure effective and safe utilization. While specific details on HealthCCSng's training were not extensively provided, general AI implementation frameworks emphasize policy documentation, staff training, and continuous monitoring.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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