CurveBeam AI's OssViewTM, a pioneering bone frailty program, has been designated as a breakthrough product by the U.S. Food and Drug Administration (FDA). OssView introduces the concept of a Structural Fragility Score (SFS), which assesses bone microstructural degradation and assists healthcare professionals in evaluating fracture risk for women aged 70 and above.
Currently, the standard method for identifying patients at risk of fragility fractures is dual energy X-ray assessments of bone mineral density (DXA). Additional fracture risk software programs are sometimes used to further assess fracture risk. However, the effectiveness of these approaches has been limited. The performance of SFS has shown significant promise when compared to these existing methods, leading to its Breakthrough Device Designation.
SFS is calculated through a wrist scan utilizing high-resolution peripheral quantitative computed tomography (HR-pQCT). CurveBeam AI aims to offer point-of-care, high-resolution CT systems for medical professionals working with non-osteoporotic patients.
By enabling quick, simple, and secure evaluation of bone architecture deterioration, SFS assists physicians in identifying patients at risk of fracture due to osteopenia or normal bone density. This facilitates the provision of appropriate care to reduce the incidence of fragility fractures.
