Image: HealthOST AI software measures vertebral compression fractures and low bone density (Photo courtesy of Nano X Imaging)
Measurements of vertebral fractures and low bone density have been shown to increase the identification of patients with musculoskeletal disease of the spine, such as osteoporosis. According to the World Congress of Osteoporosis, 75% of compression fractures are missed or not reported. Now, a new AI software provides qualitative and quantitative analysis of the spine from CT to support clinicians in the evaluation and assessment of musculoskeletal disease.
Nano X Imaging Ltd.’s (Neve Ilan, Israel) deep-learning medical imaging analytics subsidiary, Nanox.AI, has received FDA 510(k) clearance for its HealthOST device, which enables fully automated spinal analysis of vertebral compression fractures and low bone density often associated with osteoporosis. HealthOST offers a more detailed evaluation, including the ability to measure fractures more precisely, potentially aiding clinicians in evaluating risk factors for osteoporosis. The company’s AI solution automatically identifies findings suggestive of compression fractures and low bone density, enabling further work up and treatment of patients diagnosed with osteoporosis to prevent potentially life-changing major osteoporotic fractures, such as a hip fracture.
HealthOST provides qualitative and quantitative analysis of the spine, including labeling of T1-L4 vertebrae, measurement of height loss in each vertebra (T1-L4) and measurement of the mean Hounsfield Units (HU) 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.
“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,” said Pini Ben Elazar, General Manager of Nanox.AI. “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.”
“This FDA clearance is yet another step in our commitment to delivering technologies that promote population health and value-based care,” said Erez Meltzer, Chief Executive Officer of Nanox. “AI technologies like HealthOST are poised to support routine clinical decision making and potentially improve patients’ health outcomes.”
Nano X Imaging Ltd.