NANO-X IMAGING LTD announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd, has received EU MDR CE mark certification for HealthOST. HealthOST is a Software as a Medical Device (SaMD) designed for bone health analysis, enabling its commercialization across Europe.
HealthOST, an advanced Bone Solution, analyzes routine CT scans to assess vertebral height loss and bone mineral density. Building on its FDA 510(k) clearance from April 2022, it provides qualitative and quantitative analysis of the spine to support clinicians in evaluating musculoskeletal diseases like osteoporosis.
This certification is significant for Europe, where over 25.5 million women have osteoporosis and the annual cost of related fractures exceeds €56 billion. HealthOST integrates seamlessly with existing PACS, offering a cost-effective screening tool that requires no additional imaging or radiation exposure for patients, thereby addressing a critical gap in early detection of vertebral compression fractures.
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