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FDA adds OssView bone fragility software to breakthrough program

Melbourne, Australia-based CurveBeam AI is investigating how calculating a Structural Fragility Score a bone fragility measure can support clinical decisions and improve patient care.

OssView isn’t yet available for purchase in the usa, however the FDA Breakthrough Devices Program boosts development, assessment and review, while preserving the agency’s standards for premarket approvals, based on the announcement.

The existing standard of care to find out fragility fracture risk in patients is bone mineral density (BMD) measurements obtained via dual energy X-Ray. In some instances, other fracture risk software tools are accustomed to analyze fracture risk.

However, bone relative density defined-osteoporosis can miss around 80% of fragility fractures, & most fractures occur in women with a minor degree bone mineral strength (BMS) loss, based on the company.

“Even modest bone loss producing osteopenia concurrently destroys the architecture of bone which weakens the bone greatly,” Ego Seeman, professor of medicine and an endocrinologist at Austin Health, University of Melbourne, said in aprepared statement.

In comparison with BMD along with other standard measures, the Structural Fragility Score, or SFS,diagnostic calculated from the high-resolution peripheral quantitative computed tomography scan of the wrist shows greater capability to assess fracture risk.

“The countless ladies in the city with osteopenia that are vulnerable to a fracture are unlikely to be offered treatment due to the mistaken belief that finding BMD in the osteopenia range means the bone isn’t fragile,” said Seeman.

As medical technologies evolve, agencies are challenged to help keep pace, and researchers say theFDA is responding to the surge.

Andrea Fox is senior editor of Healthcare IT News.

Healthcare IT News is really a HIMSS publication.

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