The U.S. Food and Drug Administration (FDA) has designated CurveBeam AI's OssViewTM, a novel bone frailty programme, as a breakthrough product.
OssView generates a Structural Fragility Score (SFS), which measures bone microstructural degradation and serves as clinical assistance to help a healthcare professional assess the risk of fracture in females over the age of 70.
Currently, dual energy X-ray assessments of bone mineral density (BMD) are the current standard of care for identifying patients who are at risk of fragility fractures (DXA). Other fracture risk software programmes may occasionally be utilized to further determine fracture risk.
Performance of these strategies has been constrained thus far. SFS has demonstrated performance to support a Breakthrough Device Designation when measured against these methods.
SFS is determined from a wrist scan using high resolution peripheral quantitative computed tomography (HR-pQCT). For medical professionals dealing with patients who are not osteoporotic, CurveBeam AI intends to provide point-of-care, high resolution CT systems.
SFS facilitates quick, simple, and secure evaluation of bone architecture deterioration. This test aids a physician in identifying patients at risk of fracture due to osteopenia or normal bone density. This is so that appropriate care can be offered to reduce the incidence of fragility fractures.