Tool for measuring bone fragility in older women receives breakthrough device designation
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The FDA has granted breakthrough device designation to a clinical tool for determining bone fragility and fracture risk for older women, according to an industry press release.
OssView (CurveBeam AI, Ltd.) is a clinical aid that calculates a structural fragility score to determine bone microstructural deterioration in women aged older than 70 years. The structural fragility score is calculated using a high-resolution peripheral quantitative computed tomography scan of the wrist. In the press release, CurveBeam AI states its goal is to provide point of care, high-resolution CT platforms to improve access to medical providers for people without osteoporosis.
According to the press release, the OssView structural fragility score improves on the current standard of care for measuring bone mineral density via DXA. The clinical tool helps providers identify patients with osteopenia or normal bone density who are at risk for fracture and allows those patients to receive treatment to prevent fragility fractures.
"Even modest bone loss producing osteopenia concurrently destroys the architecture of bone, which weakens the bone greatly," Ego Seeman, MD, medical director of endocrinology for CurveBeam AI and professor of medicine and endocrinologist in the departments of medicine and endocrinology at Austin Health and the University of Melbourne in Australia, said in a press release. "An increase in holes in the outer shell of the bone reduces bone strength to the seventh power, loss of the inner honey-comb spongy bone reduce strength to the third power; disproportionate to the bone loss producing this destruction and disproportionate to the modest reduction in BMD found in osteopenia.”
The new clinical aid is currently available for investigational use only and is not available for sale in the U.S.
"We are extremely pleased to be moving forward with the structural fragility score diagnostic through the FDA breakthrough device program," Greg Brown, CEO of CurveBeam AI, said in a press release. "There is a clear need for an improved clinical aid like structural fragility score to help clinicians more effectively assess bone health and prevent fractures. We are looking forward to progressing its clearance with the FDA."
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