AI Software HealthOST Gets FDA 510(k) Clearance for Enhanced CT Analysis of Vertebral Compression Fractures

Seventy-five percent of compression fractures are misdiagnosed or not reported, according to the World Congress of Osteoporosis. However, an emerging artificial intelligence (AI) software platform, which just received FDA 510(k) clearance, may help improve the assessment of vertebral compression fractures with computed tomography (CT).

Nanox said the AI software HealthOST provides enhanced qualitative and quantitative analysis of spine CT images to help assess patients for musculoskeletal diseases such as osteoporosis. This analysis includes:

• labeling of T1-L4 vertebrae

• measurement of height loss in each of these vertebra

• measurement of mean Hounsfield units (HUs) in volume of interest within vertebra (T11-L4)

Indicated for patients 50 years of age and older who are getting CT imaging for at least four vertebrae in either the T1-L4 or T11-L4 areas of the spine, HealthOST helps detect findings that are suspicious for possible compression fractures and low bone density, according to Nanox.

“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 these patients who may be at risk of developing prevalent musculoskeletal conditions, such as osteoporosis, to help promote further workup and treatment of these patients,” noted Pini Ben Elazar, the general manager of Nanox.AI.