HATFIELD, Pa., Sept. 12, 2022 /PRNewswire/ -- CurveBeam AI, Ltd announced its medical diagnostic software, OssView™, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural Fragility Score (SFS), which determines bone microstructural deterioration, a clinical aid to assist a medical provider in determining bone fragility and fracture risk in over 70-year-old females.
OssView is investigational only and is not available for sale in the United States.
The goal of the FDA Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices that provide for more effective treatment or diagnosis of irreversibly debilitating diseases by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval or clearances.
Benefits associated with acceptance into the Breakthrough Devices Program include prioritized review of FDA 510(k) applications.
The current standard of care to determine fragility fracture risk in patients is bone mineral density (BMD) measurements obtained via dual energy X-Ray (DXA). In some cases, other fracture risk software tools are used to further identify fracture risk. These approaches to date have been limited in performance. When compared to these techniques, SFS has shown performance to support a Breakthrough Device Designation. Bone density defined-osteoporosis can miss up to 80%1 of fragility fractures – fractures that can be irreversibly debilitating and impact mortality.
"Most fractures occur in women with modest deficits in BMD called 'osteopenia'," said Ego Seeman, Professor of Medicine and Endocrinologist, Departments of Medicine and Endocrinology, Austin Health, University of Melbourne, Melbourne Australia. "The many women in the community with osteopenia who are at risk of a fracture are unlikely to be offered treatment because of the mistaken belief that finding BMD in the osteopenia range means the bone is not fragile."
BMD measures the amount of bone; it does not measure the breakdown of three-dimensional bone architecture.
"Even modest bone loss producing osteopenia concurrently destroys the architecture of bone which weakens the bone greatly," Seeman said. "An increase in holes in the outer shell of the bone (cortical porosity) reduces bone strength to the 7th power, loss of the inner honey-comb spongy (trabeculae) bone reduce strength to the 3rd power; disproportionate to the bone loss producing this destruction and disproportionate to the modest reduction in BMD found in osteopenia."