CT AI Software for Fracture Risk Gets Breakthrough Device Designation from FDA

The Food and Drug Administration (FDA) has granted a breakthrough device designation for OssView, a software program that may represent a significant advance over bone mineral density (BMD) measurements for assessing fragility fracture risk in women over the age of 70.

CurveBeam AI, the manufacturer of OssView, said the software assesses bone microstructural deterioration from high-resolution peripheral quantitative computed tomography (HR-pQCT) scans of the wrist and subsequently calculates a structural fragility score (SFS).

In contrast to the measurement of bone mineral content and density with BMD testing, CurveBeam AI said the SFS can provide a better evaluation of fragility fracture risk through the assessment of bone architecture. Citing previous research published in the Lancet, CurveBeam AI noted that reliance on bone density testing may miss up to 80 percent of fragility fractures.¹

“Most fractures occur in women with modest deficits in BMD called osteopenia. 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,” noted Ego Seeman, MD, an endocrinologist, and professor of medicine in the Departments of Medicine and Endocrinology at the University of Melbourne in Australia.

“There is a clear need for an improved clinical aid like SFS to help clinicians more effectively assess bone health and prevent fractures,” noted Greg Brown, the CEO of CurveBeam AI. “We are looking forward to progressing its clearance with the FDA.”

Noting that OssView is not commercially available in the United States, CurveBeam AI said the software program is currently reserved only for investigational use.

Reference

1. Samelson EJ, Broe KE, Xu H, et al. Cortical and trabecular bone microarchitecture as an independent predictor of incident fracture risk in older women and men in the Bone Microarchitecture International Consortium (BoMIC): a prospective study. Lancet Diabetes Endocrinol. 2019;7(1):34-43.