OsteoSight

OsteoSight is an AI-enabled software as a medical device (SaMD) that processes standard anteroposterior (AP) radiographs of the hip or pelvis in patients aged 50 years and older. The device operates via integration with a host integration platform that facilitates the secure transfer of DICOM images and associated metadata between OsteoSight and clinical imaging systems. As soon as OsteoSight receives a DICOM path from the host integration platform, it automatically retrieves the file from the DICOM path. After OsteoSight confirms an image is a standard AP radiograph of the hip or pelvis, it works to identify a viable Region of Interest (ROI) within the proximal femur that aligns with the “Total Hip Region”, which includes the greater trochanter, intertrochanteric, and femoral neck regions, typically analyzed in DXA scans. Only images where a viable Region of Interest (ROI) is identified are analyzed. A BMD is estimated in the femoral neck of images with a viable ROI. If an analyzed image has an estimated BMD that is less than a pre-specified threshold, the interpreting physician will receive an OsteoSight report, via the host integration platform, indicating that the patient is at risk of having low BMD. Based on the OsteoSight report and other clinical information the physician may have on the patient, physicians may be prompted to conduct further tests such as a clinical fracture risk assessment related to bone health. If an analyzed image has an estimated BMD that is greater than or equal to a pre-specified threshold, an OsteoSight report will not be generated or sent to the interpreting physician.