Nanox receives FDA 510(k) clearance for its AI HealthOST device

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Nanox has announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, recently received US Food and Drug Administration (FDA) 510(k) clearance for its HealthOST device.

HealthOST is an artificial intelligence (AI) software that aims to provide qualitative and quantitative analysis of the spine from computed tomography (CT) to support clinicians in the evaluation and assessment of musculoskeletal disease.

The device offers a fully automated spinal analysis of vertebral compression fractures and low bone density, which is often associated with osteoporosis. It is Nanox.AI’s tenth FDA clearance across its portfolio of AI clinical decision assist tools and second FDA clearance for its vertebral compression fracture device.

Pini Ben Elazar, general manager of Nanox.AI, said: “With the FDA clearance of HealthOST, we are thrilled to offer radiologists a new tool that provides deeper analysis of medical images to support identifying those patients who may be at-risk of developing prevalent musculoskeletal conditions such as osteoporosis, to help promote further work up and treatment of those patients.

“Our new product reflects our vision to create solutions to improve population health, building upon our strong track record of developing AI applications to help identify risk factors for chronic health conditions.”

HealthOST provides qualitative and quantitative analysis of the spine, including labelling of T1-L4 vertebrae, measurement of height loss in each vertebra (T1-L4) and measurement of the mean Hounsfield Units in volume of interest within vertebra (T11-L4). HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine.

Erez Meltzer, chief executive officer of Nanox, added: “This FDA clearance is yet another step in our commitment to delivering technologies that promote population health and value-based care. AI technologies like HealthOST are poised to support routine clinical decision making and potentially improve patients’ health outcomes.”


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