Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium
Nanox (NASDAQ: NNOX) has received FDA 510(k) clearance for HealthCCSng V2.0, an upgraded version of its AI-powered cardiac solution. This marks the second FDA clearance for the HealthCCSng product line. The new version introduces:
1. A 'zero calcium' category for coronary artery calcium (CAC) assessment
2. Numerical calcium scoring alongside CAC detection categories
3. Customizable CAC category configurations
HealthCCSng V2.0 analyzes non-gated, non-contrast CT scans to automatically measure CAC in patients aged 30-85. It aims to leverage routine CT scans for early detection of coronary artery disease risk. The solution has already been integrated into several healthcare systems, improving patient risk assessment and driving revenue to cardiology departments.
Nanox (NASDAQ: NNOX) ha ricevuto l'approvazione FDA 510(k) per HealthCCSng V2.0, una versione aggiornata della sua soluzione cardiaca basata sull'IA. Questo rappresenta la seconda approvazione da parte della FDA per la linea di prodotti HealthCCSng. La nuova versione introduce:
1. Una categoria di 'zero calcio' per la valutazione del calcio nelle arterie coronarie (CAC)
2. Punteggi numerici del calcio insieme alle categorie di rilevamento del CAC
3. Configurazioni personalizzabili delle categorie di CAC
HealthCCSng V2.0 analizza le TC non gated e senza contrasto per misurare automaticamente il CAC nei pazienti di età compresa tra 30 e 85 anni. Mira a sfruttare le TC di routine per una precoce individuazione del rischio di malattie coronariche. La soluzione è già stata integrata in diversi sistemi sanitari, migliorando la valutazione del rischio dei pazienti e generando entrate per i dipartimenti di cardiologia.
Nanox (NASDAQ: NNOX) ha recibido la aprobación de la FDA 510(k) para HealthCCSng V2.0, una versión mejorada de su solución cardíaca impulsada por IA. Esto marca la segunda aprobación de la FDA para la línea de productos HealthCCSng. La nueva versión presenta:
1. Una categoría de 'cálculo cero' para la evaluación del calcio en las arterias coronarias (CAC)
2. Puntuaciones numéricas de calcio junto con las categorías de detección de CAC
3. Configuraciones personalizables de categorías de CAC
HealthCCSng V2.0 analiza escaneos de TC no contrastados y no enrejados para medir automáticamente el CAC en pacientes de 30 a 85 años. Busca aprovechar los escaneos de TC rutinarios para la detección temprana del riesgo de enfermedades cardíacas. La solución ya se ha integrado en varios sistemas de salud, mejorando la evaluación del riesgo de los pacientes y generando ingresos para los departamentos de cardiología.
Nanox (NASDAQ: NNOX)는 AI 기반 심혈관 솔루션의 업그레이드 버전인 HealthCCSng V2.0에 대해 FDA 510(k) 승인을 받았습니다. 이는 HealthCCSng 제품 라인에 대한 두 번째 FDA 승인입니다. 새로운 버전은 다음을 도입합니다:
1. 관상동맥 석회화(CAC) 평가를 위한 '제로 칼슘' 카테고리
2. CAC 탐지 카테고리와 함께 칼슘 점수
3. 사용자 맞춤형 CAC 카테고리 구성
HealthCCSng V2.0은 30세에서 85세 환자의 CAC를 자동으로 측정하기 위해 비대조, 비강직 CT 스캔을 분석합니다. 이는 관상동맥 질환 위험의 조기 발견을 위해 일상적인 CT 스캔을 활용하는 것을 목표로 합니다. 이 솔루션은 이미 여러 의료 시스템에 통합되어 환자의 위험 평가를 개선하고 심장학 부서의 수익을 증가시키고 있습니다.
Nanox (NASDAQ: NNOX) a reçu l'approbation FDA 510(k) pour HealthCCSng V2.0, une version améliorée de sa solution cardiaque alimentée par IA. Cela marque la deuxième approbation de la FDA pour la ligne de produits HealthCCSng. La nouvelle version introduit :
1. Une catégorie de 'calcium zéro' pour l'évaluation du calcium des artères coronaires (CAC)
2. Un score numérique du calcium aux côtés des catégories de détection du CAC
3. Des configurations de catégories de CAC personnalisables
HealthCCSng V2.0 analyse des CT non-gated et sans contraste pour mesurer automatiquement le CAC chez des patients âgés de 30 à 85 ans. Elle vise à tirer parti des CT de routine pour une détection précoce des risques de maladies coronariennes. La solution a déjà été intégrée dans plusieurs systèmes de santé, améliorant l'évaluation des risques pour les patients et générant des revenus pour les départements de cardiologie.
Nanox (NASDAQ: NNOX) hat die FDA-Zulassung 510(k) für HealthCCSng V2.0, eine verbesserte Version seiner KI-gestützten Herzlösung, erhalten. Dies stellt die zweite FDA-Zulassung für die Produktlinie HealthCCSng dar. Die neue Version führt ein:
1. Eine 'Null-Kalzium'-Kategorie zur Bewertung von Kalzium in den Koronararterien (CAC)
2. Numerische Kalziumwerte zusammen mit CAC-Erkennungskategorien
3. Anpassbare CAC-Kategoriekonfigurationen
HealthCCSng V2.0 analysiert nicht-gated, kontrastmittelfreie CT-Scans, um automatisch CAC bei Patienten im Alter von 30 bis 85 Jahren zu messen. Ziel ist es, routinemäßige CT-Scans zur frühzeitigen Erkennung des Risikos für koronarer Herzkrankheit zu nutzen. Die Lösung wurde bereits in mehrere Gesundheitssysteme integriert, wodurch die Risikobewertung der Patienten verbessert und die Einnahmen der Kardiologie-Abteilungen gesteigert werden.
- FDA 510(k) clearance received for HealthCCSng V2.0, enhancing the product's market potential
- Introduction of 'zero calcium' category and numerical scoring improves risk assessment capabilities
- Customizable CAC category configurations allow for more precise patient evaluations
- HealthCCSng has shown tangible results in healthcare systems, driving revenue to cardiology departments
- Seamless integration with existing PACS and EMR systems
- None.
The FDA clearance for HealthCCSng V2.0 represents a significant advancement in AI-assisted cardiac risk assessment. The introduction of the 'zero calcium' category is particularly noteworthy, as it allows for more precise stratification of low-risk patients. This can potentially reduce unnecessary interventions and healthcare costs.
The addition of numerical CAC scoring alongside categories provides clinicians with more granular data, enabling finer-tuned risk assessments. This could lead to more personalized preventive strategies. The customizable CAC category configuration adds flexibility, allowing healthcare systems to adapt the tool to their specific patient populations and risk assessment protocols.
Overall, these updates should enhance the clinical utility of the HealthCCSng system, potentially improving early detection of coronary artery disease and facilitating more targeted preventive care.
This FDA clearance is a positive development for Nanox, potentially strengthening its position in the medical imaging AI market. The upgrade to HealthCCSng could drive increased adoption and revenue for several reasons:
- Enhanced clinical value may attract more healthcare systems to integrate the solution.
- The ability to identify zero CAC patients could expand the tool's use in preventive care settings.
- Customizable category configurations may appeal to a broader range of healthcare providers.
However, the financial impact remains to be seen. While the product has shown "tangible results" and driven "significant revenue" in some healthcare systems, concrete financial figures are not provided. Investors should monitor future earnings reports for evidence of increased sales and market penetration resulting from this upgrade.
The HealthCCSng V2.0 upgrade demonstrates Nanox's commitment to continuous improvement in AI-driven medical imaging analysis. The integration of more nuanced categorization and numerical scoring showcases the evolving sophistication of their algorithms.
A key technical advantage is the system's ability to utilize non-gated, non-contrast CT scans. This allows for opportunistic screening without additional radiation exposure or specialized imaging protocols, potentially increasing the tool's applicability and adoption.
The seamless integration with existing PACS and EMR systems is important for real-world implementation. However, the true test will be in the system's accuracy and consistency in real-world settings across diverse patient populations. As AI in healthcare continues to evolve, Nanox will need to demonstrate ongoing improvements and adaptability to maintain its competitive edge.
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
Marks second FDA 510(k) clearance of HealthCCSng product
PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthCCSng V2.0.
HealthCCSng V2.0 is the upgraded version of Nanox.AI’s cardiac solution, HealthCCSng, which has already shown tangible results in several healthcare systems, identifying patients at high risk of coronary artery disease while driving significant revenue to cardiology departments. It has also been seamlessly integrated with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, and enabled timely and appropriate preventive care.
HealthCCSng utilizes medical imaging data from routine non-gated, non-contrast CT scans that include the entire heart of adult patients of ages 30-85 to automatically measure coronary artery calcium (CAC), which is the number one risk predictor for a future cardiovascular event. The product aims to leverage the high utilization of CT scans in the medical care environment, including lung cancer screening programs, to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. Patients with the highest category of 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 the following 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. CAC levels of zero 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 finetune their cardiac risk assessments of patients.
- 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) categories of CAC scores. This added customization allows users to finetune their cardiac risk assessments of patients.
“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, Nanox Chief Executive Officer. “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. We will continue exploring opportunities to seamlessly integrate our AI solutions with healthcare systems and clinician workflows, and ultimately enhance patient care and outcomes.”
About Nanox.AI
Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. 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. For more information, please visit https://www.nanox.vision/ai.
About Nanox
Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. 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, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; 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 worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision.
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FAQ
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