Nano-X Imaging receives MDR CE mark for HealthOST

NANO-X IMAGING (NNOX) LTD announced that its deep-learning medical imaging analytics subsidiary, Nanox AI, has received EU MDR CE mark certification for HealthOST, an SaMD 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.