Nanox Achieves FDA Clearance for HealthCCSng V2.0 Solution
![Nanox Achieves FDA Clearance for HealthCCSng V2.0 Solution](https://investorshangout.com/images/blog/investors-hangout-newswire.jpg)
Nanox Receives FDA Clearance for HealthCCSng V2.0
HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output.
Significance of HealthCCSng V2.0
NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), a pioneering medical imaging technology company, has announced that its subsidiary, Nanox.AI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthCCSng V2.0.
This upgraded version of Nanox.AI’s cardiac solution has demonstrated significant impact across various healthcare systems by effectively identifying patients at high risk of coronary artery disease while enhancing revenue for cardiology departments. It integrates seamlessly with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, facilitating prompt and appropriate preventive care.
Utilization of Medical Imaging Data
HealthCCSng utilizes medical imaging data from routine non-gated, non-contrast CT scans that encompass the entire heart of adult patients aged 30 to 85 years to automatically measure coronary artery calcium (CAC). This is the foremost risk predictor for future cardiovascular events. The solution aims to utilize the widespread use of CT scans in medical settings—including lung cancer screening programs—to detect calcification in coronary arteries opportunistically. Individuals with the highest CAC levels are over 13 times more likely to experience a cardiac event.
Workflow and Output Enhancements
The device output is integrated into the standard workflow of radiologists, providing a list of studies that have undergone successful algorithm analysis, thereby allowing for further clinical assessments by cardiologists, general practitioners, and other healthcare professionals.
New Features of HealthCCSng V2.0
HealthCCSng V2.0 enhances its utility for physicians and optimizes their ability to conduct thorough risk assessments and subsequent preventive healthcare methodologies for patients:
- Zero CAC Category: This feature allows clinicians to easily identify patients with zero and low CAC levels, with zero CAC levels indicating a very low risk of cardiac events. This new category supplements the existing ‘low’, ‘medium’, and ‘high’ CAC categories.
- Numerical CAC Scoring: The solution now includes a numerical CAC score alongside the CAC category in its results interface, offering clinicians the ability to refine their cardiac risk assessments.
- CAC Category Configuration: Users can now modify the lower and upper bounds for varying categories of CAC scores—low (1-99 Hounsfield units), medium (100-399 HU), and high (400+ HU)—thus enabling further customization of cardiac risk assessments.
Commitment to Enhancing Healthcare
“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,” said Erez Meltzer, Chief Executive Officer of Nanox. “Our AI cardiac solution helps bridge the gap between radiology and cardiology, two specialties that often have different terminologies and evaluation methods for imaging data. It ensures patients receive appropriate preventive care that they might otherwise miss. We continue to explore opportunities for seamless integration of our AI solutions into healthcare systems and clinician workflows to improve patient care and outcomes.”
About Nanox.AI
Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. It develops solutions targeting prevalent chronic and acute diseases affecting populations globally. By leveraging AI technology, Nanox.AI extracts actionable clinical insights from routine medical imaging that may otherwise be overlooked, potentially facilitating further medical evaluations for the establishment of personalized preventive care paths for patients.
About Nanox
Nanox (NASDAQ: NNOX) aims to apply its proprietary medical imaging technology and solutions to enhance the accessibility and affordability of diagnostic medicine worldwide. The company envisions increasing access, lowering costs, and improving the efficiency of routine medical imaging technologies and processes, which are crucial 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 augment routine CT imaging readings; a cloud-based infrastructure (Nanox.CLOUD); 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 form 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 by Nanox that helps in the assessment of 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?
It 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 globally.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/