FDA Breakthrough Device Designation for Bone Fragility Software

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to CurveBeam AI, Ltd.’s medical diagnostic software, OssView™.

According to the FDA, the Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. It is a “voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

The goal of the program is to provide “patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.” At the same time, the program also aims to preserve the requirements for premarket approval, 510(k) clearance, and de novo marketing authorization.

According to CurveBeam’s press release, “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 not currently available for sale in the United States, it is investigational only.

“SFS is calculated from a high resolution peripheral quantitative computed tomography (HR-pQCT) scan of the wrist.” CurveBeam AI plans to offer point-of-care, high resolution CT platforms for non-osteoporotic patients.

Calculating a SFS allows a physician to identify patients suffering from osteopenia or patients who may have a fracture risk. This ensures that patients can receive necessary treatments and ideally avoid fragility fractures.

SFS is different from the traditional approach to determining fragility fracture risk. Currently, most physicians rely on bone mineral density (BMD) measurements provided via dual energy X-ray absorptiometry (DXA). While this test can indicate the amount of bone, it “does not measure the breakdown of three-dimensional bone architecture.”

Ego Seeman, M.D., a professor of medicine and endocrinologist at Austin Health, University of Melbourne in Melbourne, Victoria, Australia explained, “Most fractures occur in women with modest deficits in BMD called ‘osteopenia.’”

Dr. Seeman continued, “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.”

FDA Breakthrough Device Designation can speed up the development, assessment, and review of medical devices. Devices with Breakthrough Device Designation receive priority review of their FDA 510(k) applications.

Hatfield, Pennsylvania-based CurveBeam, LLC and Melbourne-based StraxCorp Pty Ltd, recently announced the formation of CurveBeam AI via a merger agreement. For OTW’s coverage of the merger, see “Introducing Curvebeam AI Limited.”