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FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FX is indicated for radiographs of the following industry-standard radiographic views and study types. | Study Type<br>(Anatomic Area<br>of Interest⁺) | Radiographic View(s)<br>Supported* | |-----------------------------------------------|------------------------------------| | Ankle | Frontal, Lateral, Oblique | | Clavicle | Frontal | | Elbow | Frontal, Lateral | | Femur | Frontal, Lateral | | Forearm | Frontal, Lateral | | Hip | Frontal, Frog Leg Lateral | | Humerus | Frontal, Lateral | | Knee | Frontal, Lateral | | Pelvis | Frontal | | Shoulder | Frontal, Lateral, Axillary | | Tibia / Fibula | Frontal, Lateral | | Wrist | Frontal, Lateral, Oblique | *For the purposes of this table, "Frontal" is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views. +Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device designed to assist clinicians in detecting fractures during the review of commonly acquired adult radiographs. FX does this by analyzing radiographs and providing relevant annotations, assisting clinicians in the detection of fractures within their diagnostic process at the point of care. FX was developed using robust scientific principles and industry-standard deep learning algorithms for computer vision. FX creates, as its output, a DICOM overlay with annotations indicating the presence or absence of fractures. If any fracture is detected by FX, the output overlay is composed to include the text annotation "Fracture: DETECTED" and to include one or more bounding boxes surrounding any fracture site(s). If no fracture is detected by FX, the output overlay is composed to include the text annotation "Fracture: NOT DETECTED" and no bounding box is included. Whether or not a fracture is detected, the overlay includes a text annotation identifying the radiograph as analyzed by FX and instructions for users to access labeling. The FX overlay can be toggled on or off by the clinicians within their PACS viewer, allowing for uninhibited concurrent review of the original radiograph.

OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists.

OsteoDetect is a software device designed to assist clinicians in detecting distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists. The software uses deep learning techniques to analyze wrist radiographs (PA and LAT views) for distal radius fracture in adult patients.