Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment
- Received EU MDR CE mark certification, enabling commercialization across Europe
- Already has FDA 510(k) clearance, showing strong regulatory validation
- Requires no additional imaging or radiation, making it cost-effective
- Demonstrated superior detection rates in ADOPT study - up to 6x more than national average
- Seamlessly integrates with existing PACS systems
- Addresses a large market with 25.5M European women having osteoporosis
- Faces challenge of integrating into established healthcare workflows
- Competition from existing bone density scanning methods
- Requires existing CT scan infrastructure to be effective
Insights
Nanox's HealthOST CE mark enables European commercialization, addressing a significant €56B market opportunity for early osteoporosis detection.
Nanox's HealthOST has achieved a critical regulatory milestone with its EU MDR CE mark, opening the entire European market for commercialization. This AI-based software as a medical device (SaMD) represents a significant advancement in preventive care for musculoskeletal diseases, particularly osteoporosis.
The technology addresses a substantial unmet medical need - according to data cited, approximately 66% of vertebral compression fractures go undetected in routine CT reporting. HealthOST's capability to identify these markers through existing CT scans represents a considerable advantage over traditional screening methods, requiring no additional imaging, radiation exposure, or patient time.
The European market presents a substantial commercial opportunity, with over 25.5 million women having osteoporosis and 23.8 million Europeans at high risk of osteoporotic fractures. The annual cost burden exceeds €56 billion, with cases projected to increase 25% by 2034 due to demographic shifts.
The ADOPT study results provide compelling evidence for HealthOST's effectiveness, identifying 3,450 new patients with vertebral compression fractures from 37,220 scans - up to six times more than the UK national average. The three-year continuation at Oxford University further validates the clinical utility.
From a technology perspective, HealthOST's seamless PACS integration enhances its commercial appeal by fitting into existing clinical workflows. As an upgraded version of HealthVCF, it builds on established technology while expanding capabilities for bone health analysis.
- HealthOST identifies vertebral height loss and bone mineral density, which are key indicators of musculoskeletal disease
- Osteoporosis is a common progressive bone disease among adults over 50 years of age that causes bones to weaken, leading to fractures
- The software provides automated quantification of vertebral parameters from routine CT scans, delivering consistent and objective data to support physician evaluation, before life-altering fractures occur
PETACH TIKVA, Israel, June 05, 2025 (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 Ltd, has received EU MDR CE (Conformité Européenne) mark certification for HealthOST, an SaMD (Software as a medical device) for bone health analysis, enabling its commercialization across Europe and ensuring compliance with the highest regulatory standards for medical software.
HealthOST is Nanox.AI’s advanced Bone Solution, which analyzes routine CT scans to assess vertebral height loss and bone mineral density. Building on its FDA 510(k) clearance received in April 2022, HealthOST leverages AI to provide qualitative and quantitative analysis of the spine from CT scans to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine, such as osteoporosis, which can remain undiagnosed until life-altering fractures occur.
Since the CT scans analyzed by HealthOST were performed for other clinical indications, no additional imaging, radiation or patient time is required, making it a cost-effective screening tool. HealthOST is seamlessly integrated with existing picture archiving and communication systems (PACS), and can enable timely and appropriate preventive care.
Osteoporosis is a common progressive bone disease among adults over 50 years of age that causes bones to weaken, leading to fractures. According to the World Congress of Osteoporosis, an estimated
"This CE mark for HealthOST represents a significant expansion of our AI capabilities in Europe," said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. "Our AI technology demonstrates the Nanox end-to-end solution that can deliver immediate practical value to opportunities for proactive care. By integrating seamlessly into routine CT scans, HealthOST helps healthcare providers maximize their existing resources, while identifying patients who might otherwise fall through the cracks of traditional screening methods."
HealthOST is the upgraded version of HealthVCF, which was evaluated in the AI-enabled Detection of OsteoPorosis for Treatment (ADOPT) study at four UK National Health Services (NHS) trusts – Cambridge, Bradford, Cardiff and Southampton – and coordinated by the long-standing clinical users at Oxford.
In the ADOPT study, HealthVCF analyzed 37,220 routine medical CT scans and identified over 3,450 new patients with vertebral compression fractures, up to six times more than the national average at NHS hospitals in the UK. These patients were asymptomatic, and the data underscores the importance of addressing the critical gap in detection of patients with vertebral fractures.
“Nanox.AI bone solution has proven to be a game-changer in bone health management," said Professor Kassim Javaid of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford. "After successful integration with our clinical pathways, we saw its significant impact and chose to continue with it for another three years at Oxford. By enabling earlier identification of patients with vertebral fractures, Nanox.AI bone solution improved our system identification of patients at high fracture risk to improve patient outcomes and reduce the burden on healthcare systems through preventive care.”
Healthcare facilities interested in implementing HealthOST can visit https://www.nanox.vision/ai-bone-solution/ for more information.
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, Nanox.AI helps clinicians extract valuable and actionable clinical insights from 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 www.nanox.vision/ai.
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 proprietary digital X-ray 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 to enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment 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 LTD – 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
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Contacts
Media Contact:
Ben Shannon
ICR Healthcare
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@icrhealthcare.com
References
i International Osteoporosis Foundation. (n.d.). Epidemiology of osteoporosis and fragility fractures. Retrieved December 13, 2024, from https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures
ii Kanis, J. A., Cooper, C., Rizzoli, R., & Reginster, J. Y. (2021). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Archives of Osteoporosis, 16(1), 1-10. https://doi.org/10.1007/s11657-021-00969-8
FAQ
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