FDA Clears Nanox.AI’s Coronary Artery Assessment Tech

NANO-X Imaging Ltd.’s deep-learning medical imaging analytics subsidiary, Nanox.AI, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its upgraded cardiac assessment solution. 
 
HealthCCSng V2.0 is the latest version of Nanox.AI’s cardiac evaluation technology, HealthCCSng, which has shown tangible results in several healthcare systems by identifying patients at high risk of coronary artery disease. It has also been seamlessly integrated with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, and has enabled timely and appropriate preventive care.
 
HealthCCSng uses medical imaging data from routine non-gated, non-contrast computed tomography (CT) scans that include the entire heart of adult patients (ages 30-85) to automatically measure coronary artery calcium (CAC), the top risk predictor for a future cardiovascular event. The product is made to leverage the high use of CT scans in the medical care environment, including lung cancer screening programs, to automatically detect calcification in the coronary arteries in an opportunistic manner. Patients with the highest CAC levels are over 13 times more likely to suffer a cardiac event.
 
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.
 
HealthCCSng V2.0 introduces several features that improve its ability to inform physicians and help them conduct the most appropriate risk assessment and subsequent preventative healthcare for patients:

• Zero CAC Category: HealthCCSng now enables clinicians to easily distinguish between patients with zero and low CAC levels. Zero CAC levels are associated with very low risk of cardiac events. The new zero CAC category joins the previously featured “low,” “medium,” and “high” CAC categories.
• Numerical CAC Scoring: HealthCCSng now provides the numerical CAC score alongside the CAC category in its results interface, allowing clinicians to fine-tune their cardiac risk assessments.
• CAC Category Configuration: HealthCCSng now 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) CAC score categories. This added customization allows users to adjust their cardiac risk assessments. 

“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,” Nanox CEO Erez Meltzer said. “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 they can be directed to appropriate preventative healthcare. We will continue exploring opportunities to seamlessly integrate our AI solutions with healthcare systems and clinician workflows, and ultimately enhance patient care and outcomes.”
 
Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Its solutions are developed to target highly prevalent chronic and acute diseases affecting large populations worldwide. Leveraging AI technology, Nanox.AI helps clinicians extract valuable and actionable clinical insights from routine medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. 
 
Nanox applies its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable globally. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a solution that connects medical imaging solutions, from scan to diagnosis.