Nanox.ARC Imaging System Receives FDA Clearance for General Use, Including Pulmonary Indication
Nanox (NASDAQ: NNOX) has received FDA 510(k) clearance for its Nanox.ARC imaging system for general use, including pulmonary, intra-abdominal, and paranasal sinus indications, expanding from its previous musculoskeletal system clearance. The system features proprietary digital X-ray technology with cold cathode tomosynthesis, providing enhanced 3D visualization compared to traditional 2D X-rays.
The Nanox.ARC is currently deployed across seven U.S. states, with dozens of units in various stages of deployment worldwide. The system is designed for professional healthcare facilities and operated by trained medical professionals. It offers potential benefits including reduced patient wait times, faster diagnosis, and improved workflow integration, while requiring less space and power than traditional X-ray machines.
Nanox (NASDAQ: NNOX) ha ricevuto l'approvazione 510(k) dalla FDA per il suo sistema di imaging Nanox.ARC per uso generale, comprese le indicazioni polmonari, intra-addominali e dei seni paranasali, ampliando la sua precedente approvazione per il sistema muscoloscheletrico. Il sistema è dotato di una tecnologia digitale di raggi X proprietaria con tomosintesi a catodo freddo, che offre una visualizzazione 3D migliorata rispetto ai tradizionali raggi X 2D.
Il Nanox.ARC è attualmente operante in sette stati degli USA, con diverse unità in varie fasi di distribuzione in tutto il mondo. Il sistema è progettato per strutture sanitarie professionali e viene gestito da professionisti medici qualificati. Offre vantaggi potenziali come tempi di attesa ridotti per i pazienti, diagnosi più rapide e una migliore integrazione del flusso di lavoro, richiedendo meno spazio e potenza rispetto alle tradizionali macchine a raggi X.
Nanox (NASDAQ: NNOX) ha recibido la autorización 510(k) de la FDA para su sistema de imágenes Nanox.ARC para uso general, incluyendo indicaciones pulmonares, intraabdominales y de senos paranasales, ampliando su autorización previa para el sistema musculoesquelético. El sistema cuenta con tecnología digital de rayos X propia con tomosíntesis de cátodo frío, lo que proporciona una visualización 3D mejorada en comparación con los rayos X 2D tradicionales.
El Nanox.ARC está actualmente en uso en siete estados de EE. UU., con decenas de unidades en varias etapas de implementación en todo el mundo. El sistema está diseñado para instalaciones de atención médica profesional y es operado por profesionales médicos capacitados. Ofrece beneficios potenciales como la reducción del tiempo de espera para los pacientes, un diagnóstico más rápido y una mejor integración del flujo de trabajo, mientras que requiere menos espacio y energía que las máquinas de rayos X tradicionales.
Nanox (NASDAQ: NNOX)는 Nanox.ARC 이미징 시스템에 대해 FDA 510(k) 승인을 받았으며, 이는 호흡기, 복부 내 및 부비동 표시를 포함한 일반 사용을 위한 것입니다. 이는 이전의 근골격계 시스템 승인을 확장한 것입니다. 이 시스템은 독자적인 디지털 X선 기술과 냉음극 단층촬영을 갖추고 있어 전통적인 2D X선보다 향상된 3D 시각화를 제공합니다.
Nanox.ARC는 현재 7개 주에서 운영되고 있으며, 전 세계 여러 단계에서 배포 중인 여러 대의 장비가 있습니다. 이 시스템은 전문 의료 시설을 위해 설계되었으며, 훈련된 의료 전문가에 의해 운영됩니다. 이는 환자의 대기 시간 단축, 더 빠른 진단, 향상된 작업 흐름 통합 등 잠재적인 이점을 제공하며, 전통적인 X선 기계에 비해 더 적은 공간과 전력을 요구합니다.
Nanox (NASDAQ: NNOX) a reçu l'approbation 510(k) de la FDA pour son système d'imagerie Nanox.ARC à usage général, y compris des indications pulmonaires, intra-abdominales et de sinus paranasaux, élargissant son approbation précédente pour le système musculosquelettique. Ce système est équipé d'une technologie de radiographie numérique propriétaire avec tomosynthèse à cathode froide, offrant une visualisation 3D améliorée par rapport aux radiographies 2D traditionnelles.
Le Nanox.ARC est actuellement déployé dans sept États américains, avec des dizaines d'unités à différents stades de déploiement dans le monde entier. Le système est conçu pour les établissements de santé professionnels et est opéré par des professionnels de santé formés. Il offre des avantages potentiels tels que la réduction des temps d'attente pour les patients, des diagnostics plus rapides et une meilleure intégration des flux de travail, tout en nécessitant moins d'espace et d'énergie que les machines à rayons X traditionnelles.
Nanox (NASDAQ: NNOX) hat die FDA-510(k)-Genehmigung für sein Nanox.ARC-Bildgebungssystem für den allgemeinen Gebrauch erhalten, einschließlich Indikationen für die Lunge, den intraabdominalen Bereich und die Nasennebenhöhlen, wodurch die vorherige Genehmigung für das muskuloskelettale System erweitert wurde. Das System verfügt über proprietäre digitale Röntgentechnologie mit Kaltkathoden-Tomosynthese, die eine verbesserte 3D-Visualisierung im Vergleich zu herkömmlichen 2D-Röntgenaufnahmen bietet.
Das Nanox.ARC ist derzeit in sieben Bundesstaaten der USA im Einsatz, mit Dutzenden von Geräten in verschiedenen Phasen der weltweiten Einführung. Das System ist für professionelle Gesundheitseinrichtungen konzipiert und wird von geschulten medizinischen Fachkräften betrieben. Es bietet potenzielle Vorteile wie kürzere Wartezeiten für Patienten, schnellere Diagnose und verbesserte Workflow-Integration, während es weniger Platz und Strom benötigt als herkömmliche Röntgengeräte.
- FDA 510(k) clearance expansion to include additional critical medical indications
- Commercial deployment already active across seven U.S. states
- Several dozen units in various stages of deployment globally
- Smaller footprint and lower power requirements compared to traditional X-ray machines
- current deployment scope with only 'few dozen' units worldwide
- Requires specialized trained personnel for operation
Insights
The FDA clearance for expanded indications of the Nanox.ARC system represents a significant milestone for NNOX. The approval now covers essential diagnostic areas including pulmonary, intra-abdominal and paranasal applications, substantially broadening the device's market potential beyond just musculoskeletal imaging.
The technology's key advantages include:
- Advanced tomosynthesis with cold cathode technology enabling 3D imaging
- Smaller footprint compared to traditional X-ray machines
- Lower power requirements
- Improved image quality through matrix pattern noise reduction
With units already deployed across seven U.S. states and dozens more in various stages of deployment globally, the expanded clearance could accelerate commercial adoption. The system's design for integration into existing clinical workflows and potential to reduce patient wait times addresses critical healthcare efficiency needs.
The expanded FDA clearance positions NNOX to compete more effectively in the
Key market implications include:
- Broader addressable market across hospitals, clinics and imaging centers
- Potential for increased revenue streams through diverse clinical applications
- Competitive advantage in the digital X-ray space due to proprietary technology
The current deployment across seven states provides a foundation for expansion, while positive feedback from early adopters like the Diagnostic Radiology Institute of Kansas City could help drive further market penetration.
- Nanox.ARC receives additional FDA clearance to produce tomographic images for general use, including pulmonary, intra-abdominal and paranasal indications, in addition to its previously cleared indication for the musculoskeletal system
- Nanox.ARC uses high voltage powered digital X-ray tubes for 3D tomosynthesis imaging that could help expand availability of medical imaging
- Nanox.ARC now deployed at healthcare facilities across seven states in the U.S.
PETACH TIKVA, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nanox.ARC, a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.
The Nanox.ARC features a proprietary digital X-ray source, representing a significant advancement in X-ray technology. The Nanox.ARC utilizes advanced tomosynthesis technology with a cold cathode to create a more comprehensive, sliced three-dimensional view of the body, enhancing visualization with multiple layers of images and reducing the super-imposition of structures often seen in 2D X-rays.
“With this FDA clearance, we can now offer U.S. healthcare providers significantly broader imaging capabilities that are akin to commonly used traditional X-ray devices,” said Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman. “Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC – an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. We look forward to bringing this technology to more healthcare facilities throughout the country.”
The Company believes the new FDA-cleared indications will help broaden Nanox. ARC’s commercial expansion in the U.S., where it is currently deployed at multiple healthcare facilities across seven states. Worldwide, there are a few dozen units in various stages of shipments and deployments for both commercial and clinical uses.
“The installation of the Nanox.ARC at our facility marks a significant leap forward in our diagnostic capabilities,” said Sherri Donaldson, COO at Diagnostic Radiology Institute of Kansas City, located in Mission, Kansas. “This technology allows us to provide our patients with advanced imaging services, potentially reducing wait times and improving the overall patient experience. We're excited to be at the forefront of this technological advancement in medical imaging.”
The Nanox.ARC is intended for use in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers and other medical practices, and is operated by trained radiographers, radiologists and physicians. It is designed to allow easy and efficient integration into current clinical workflows. The Nanox.ARC has the potential benefits of reducing patient wait times, enabling faster care and more efficient diagnosis, while also potentially reducing the need to visit a separate imaging facility.
“Digital tomosynthesis provides added value in certain clinical situations. Musculoskeletal, thoracic and abdominal imaging all have use cases that may be best served by digital tomosynthesis compared to CT or radiography,” said Greg Kicska M.D., Ph.D, Assistant Professor at Harborview Medical Center and Nanox Advisory Board Member. “The Nanox system is also unique in that it doesn’t have as large a footprint as traditional X-ray machines, doesn’t require as much power and utilizes a matrix pattern that blurs out structural noise, making images more clean.”
About Nanox
Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and novel digital source.
Nanox's vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI for smarter diagnostics and maintaining a clinically-driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI – an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages and stores data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – 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. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. For more information, please visit www.nanox.vision.
Forward-Looking Statements
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xii) potential litigation associated with our transactions.
For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations.
Contacts
Media Contact:
Ben Shannon
ICR Healthcare
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@westwicke.com
FAQ
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