Nanox Receives FDA Clearance for HealthCCSng V2.0
The latest version of HealthCCSng, known as V2.0, introduces a new ‘zero calcium’ classification for coronary artery calcium (CAC) and provides a numerical score that corresponds to the detected CAC category.
Importance of HealthCCSng V2.0
NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX) is a leading innovator in medical imaging technology. The company has announced that its subsidiary, Nanox.AI, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthCCSng V2.0.
This enhanced version of Nanox.AI’s cardiac solution has shown a significant impact on various healthcare systems by effectively identifying patients who are at a high risk for coronary artery disease, while also boosting revenue for cardiology departments. It integrates smoothly with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, ensuring timely and appropriate preventive care.
Using Medical Imaging Data
HealthCCSng leverages medical imaging data from routine non-gated, non-contrast CT scans that cover the entire heart of adult patients aged 30 to 85 years to automatically assess coronary artery calcium (CAC). This measurement is the primary risk indicator for future cardiovascular events. The solution aims to capitalize on the widespread use of CT scans in medical settings—including lung cancer screening programs—to opportunistically detect calcification in coronary arteries. Individuals with the highest CAC levels are over 13 times more likely to experience a cardiac event.
Improvements in Workflow and Output
The device’s output is seamlessly integrated into the standard workflow of radiologists, providing a list of studies that have successfully undergone algorithm analysis. This allows cardiologists, general practitioners, and other healthcare professionals to conduct further clinical assessments.
New Features of HealthCCSng V2.0
HealthCCSng V2.0 enhances its functionality for physicians, improving their ability to perform thorough risk assessments and implement subsequent preventive healthcare strategies for patients:
- Zero CAC Category: This feature enables clinicians to easily identify patients with zero and low CAC levels, where zero CAC indicates a very low risk of cardiac events. This new category complements the existing ‘low’, ‘medium’, and ‘high’ CAC classifications.
- Numerical CAC Scoring: The updated solution now includes a numerical CAC score alongside the CAC category in its results interface, allowing clinicians to refine their cardiac risk evaluations.
- CAC Category Configuration: Users can now adjust the lower and upper limits for different CAC score categories—low (1-99 Hounsfield units), medium (100-399 HU), and high (400+ HU)—enabling further customization of cardiac risk assessments.
Dedication to Improving Healthcare
“We are excited to receive another regulatory clearance from the FDA for our AI cardiac solution, which includes updates that demonstrate our commitment to providing healthcare professionals with essential tools,” stated Erez Meltzer, Chief Executive Officer of Nanox. “Our AI cardiac solution helps bridge the gap between radiology and cardiology, two fields that often use different terminologies and evaluation methods for imaging data. It ensures that patients receive the preventive care they might otherwise miss. We are continuously exploring ways to integrate our AI solutions into healthcare systems and clinician workflows to enhance patient care and outcomes.”
About Nanox.AI
Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. It focuses on developing solutions for common chronic and acute diseases that affect populations around the world. By harnessing AI technology, Nanox.AI extracts actionable clinical insights from routine medical imaging that may otherwise be overlooked, potentially facilitating further medical evaluations and establishing personalized preventive care paths for patients.
About Nanox
Nanox (NASDAQ: NNOX) aims to utilize its proprietary medical imaging technology and solutions to enhance the accessibility and affordability of diagnostic medicine globally. The company envisions increasing access, reducing costs, and improving the efficiency of routine medical imaging technologies and processes, which are essential for better health outcomes and saving lives. Nanox's ecosystem includes Nanox.ARC—an economical and user-friendly multi-source Digital Tomosynthesis system; an AI-based suite of algorithms to enhance routine CT imaging readings; a cloud-based infrastructure (Nanox.CLOUD); a proprietary decentralized marketplace through its subsidiary USARAD Holdings Inc., providing remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, these products and services create an innovative and extensive solution that connects medical imaging processes from scan to diagnosis.
Frequently Asked Questions
What is HealthCCSng V2.0?
HealthCCSng V2.0 is an upgraded AI cardiac solution from Nanox that assists in assessing coronary artery calcium (CAC).
What new features does HealthCCSng V2.0 offer?
The new features include a zero CAC category, numerical CAC scoring, and customizable CAC category configurations.
How does HealthCCSng impact patient care?
This solution aids healthcare professionals in risk assessment, ensuring patients receive timely preventive care for coronary artery disease.
What technologies does Nanox utilize?
Nanox employs AI technology and deep learning analytics to enhance medical imaging and provide actionable insights from routine scans.
What is Nanox's mission?
Nanox aims to make diagnostic medicine more accessible and affordable by improving the efficiency of medical imaging processes worldwide.
