FDA clear artificial intelligence software measuring BMD, fractures
The FDA has given 510(k) clearance for artificial intelligence software developed to support providers in the evaluation and assessment of musculoskeletal disease for older adults, according to an industry press release.
The HealthOST Device (Nanox Imaging Ltd.) provides a qualitative and quantitative analysis of the spine from CT imaging. The software’s analysis includes labeling of T1-L4 vertebrae, measurement of height loss in each vertebra, and measurement of mean Hounsfield Units in volume of interest within vertebra. The software automatically identifies findings suggestive of compression fractures and low bone mineral density, allowing providers to treat people with osteoporosis.
HealthOST is indicated for use in adults aged 50 years and older undergoing a CT scan for any clinical indication that includes at least four vertebrae in the T1-L4 and T11-L4 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,” Pini Ben Elazar, general manager of Nanox AI, said in a press release. “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.”