Nanox AI receives EU MDR CE mark certification for bone health analysis software.

Nanox AI Ltd's HealthOST software has received EU MDR CE certification for bone health analysis. HealthOST uses CT scans to quantify vertebral height loss and bone mineral density, key indicators of osteoporosis. The software delivers consistent and objective data to support physician evaluation, reducing the risk of fractures. This certification enables commercialization in Europe and ensures compliance with highest regulatory standards for medical software.

Nanox AI Ltd, a subsidiary of Nanox Imaging Ltd, has received EU MDR CE certification for its HealthOST software, marking a significant milestone in the company's mission to advance preventive healthcare through advanced AI technology. HealthOST, an SaMD (Software as a Medical Device), has been granted approval for bone health analysis, enabling its commercialization across Europe and ensuring compliance with the highest regulatory standards for medical software.

HealthOST utilizes AI to analyze routine CT scans, providing qualitative and quantitative assessments of the spine to support clinicians in the evaluation and assessment of musculoskeletal diseases, such as osteoporosis. The software identifies vertebral height loss and bone mineral density, key indicators of osteoporosis, which often remains undetected until life-altering fractures occur. By leveraging existing CT scans, HealthOST offers a cost-effective and non-invasive screening tool that can be seamlessly integrated into existing picture archiving and communication systems (PACS).

Osteoporosis is a prevalent condition among adults over 50 years of age, with a significant impact on healthcare systems worldwide. 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. Early detection is crucial, as modern treatments can improve bone strength and reduce fracture risk, helping patients maintain independence and reducing healthcare needs.

The EU MDR CE certification for HealthOST represents a significant expansion of Nanox AI's AI capabilities in Europe. The software's ability to deliver immediate practical value and integrate seamlessly into routine CT scans highlights the company's commitment to maximizing existing healthcare resources and addressing critical gaps in patient detection. This certification follows Nanox AI's FDA 510(k) clearance received in April 2022.

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. The study demonstrated the software's potential to identify up to six times more patients with vertebral compression fractures than the national average, underscoring the importance of earlier identification and proactive care.

Healthcare facilities interested in implementing HealthOST can visit [Nanox AI's website](https://www.nanox.vision/ai-bone-solution/) for more information.

References:
[1] Nanox AI Ltd. (2025). Nanox Receives MDR-CE Mark for HealthOST. Retrieved from https://www.marketscreener.com/quote/stock/NANO-X-IMAGING-LTD-111120492/news/Nanox-Receives-MDR-CE-Mark-for-HealthOST-an-Advanced-AI-Powered-Software-for-Spine-Assessment-50167477/