AI-driven Spine Assessment Software Approved by Nanox under CE Mark
In a significant development for the European healthcare sector, Nanox Imaging Ltd, a leading medical imaging technology company, has secured EU MDR CE mark certification for its AI-powered spine assessment software, HealthOST. This certification allows for the commercial deployment of HealthOST across European countries, positioning it as an advanced tool for improving bone health diagnostics.
HealthOST is an SaMD (Software as a Medical Device) for bone health analysis, developed by Nanox AI Ltd. The software leverages AI to provide qualitative and quantitative analysis of the spine from CT scans, enhancing bone health analysis by improving the detection and monitoring of conditions such as osteoporosis through automated spine analysis.
A scientific evaluation published in June 2025 found that HealthOST's AI assessment performed well against consensus expert opinions, suggesting strong clinical reliability and potential to support diagnostic workflows. This has been demonstrated in practical applications, with the Nanox.AI bone solution enabling earlier identification of patients with vertebral fractures, improving the system's identification of patients at high fracture risk.
The annual cost of osteoporosis-related fractures in Europe exceeds 56 billion EUR, with cases expected to increase 25% by 2034 due to an aging population. Osteoporosis, a common progressive bone disease among adults over 50 years of age that causes bones to weaken, leading to fractures, poses a significant burden on healthcare systems.
HealthOST analyses routine CT scans to assess vertebral height loss and bone mineral density, potentially improving the detection of vertebral fractures, which are often underreported or undetected. According to the World Congress of Osteoporosis, an estimated 66% of vertebral compression fractures, a strong indicator of osteoporosis, go undetected or unreported in routine CT diagnostic reporting.
The potential benefits of the Nanox.AI bone solution include earlier identification of patients at risk of osteoporosis-related fractures and improved patient outcomes through preventive care. In the ADOPT study, HealthVCF, HealthOST's predecessor, analysed 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.
Professor Kassim Javaid of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, stated that the Nanox.AI bone solution has proven to be a game-changer in bone health management. The solution aims to improve patient outcomes and reduce the burden on healthcare systems through preventive care.
With HealthOST seamlessly integrated with existing picture archiving and communication systems (PACS), its cost-effective screening tool status, requiring no additional imaging, radiation, or patient time, it is set to make a significant impact in Europe's healthcare settings. The impact is expected to be significant, potentially advancing early osteoporosis detection and spine health assessment efficiency using AI technology in Europe’s healthcare settings.
- The regulatory standards for medical devices have been met by Nanox Imaging Ltd's HealthOST, a digital health solution for bone health analysis, as it has secured EU MDR CE mark certification.
- HealthOST, an SaMD developed by Nanox AI Ltd, utilizes artificial intelligence to analyze spine health from CT scans, aiming to support diagnostic workflows and improve healthcare-and-wellness outcomes for patients.
- The use of HealthOST has the potential to disrupt therapies-and-treatments for osteoporosis, a significant burden on European healthcare systems, by identifying patients at risk of osteoporosis-related fractures earlier and improving preventive care.
- The integration of HealthOST with existing technology such as picture archiving and communication systems (PACS) makes it a cost-effective, radiation-free, and time-efficient tool for advancing digital health, particularly in the field of spine health assessment.
