The U.S. Food and Drug Administration (FDA) has granted CurveBeam AI's OssView bone fragility assessment software breakthrough device designation.
Current standard of care for assessing bone fragility and fracture risk is bone mineral density measurements taken on dual-energy x-ray absorptiometry (DEXA), but this technology has limitations, CurveBeam AI said.
OssView evaluates bone deterioration on a microstructural level and offers what the company calls a structural fragility score, calculating the extent of a patient's bone fragility from high-resolution, peripheral quantitative CT scans of the wrist. Physicians can then use the results to identify patients with osteopenia and to set preventive treatment measures, according to CurveBeam AI.
