FractureDetect (FX)
Imagen Technologies, Inc.FractureDetect (FX) is an AI-powered software that analyzes X-ray images of bones to help doctors detect fractures. It highlights areas on radiographs where fractures are detected, improving accuracy and efficiency in diagnosis for various bone regions in adults.
Intended Use
FractureDetect (FX) is a computer-assisted detection and diagnosis software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. It supports multiple standard radiographic views for various skeletal regions.
Technology
FractureDetect (FX) uses supervised deep learning (a type of machine learning) to analyze X-ray radiographs from various anatomical regions of the musculoskeletal system. It processes DICOM images from standard imaging devices or DICOM nodes, providing a toggleable annotation overlay on the original image within a PACS system to highlight fractures. It operates securely with HIPAA compliance.
Performance
Performance testing included evaluation of 11,970 radiographs from multiple anatomical areas. The device demonstrated high sensitivity (95.1%), specificity (89.3%), and area under the curve (0.982). A clinical reader study showed significantly improved diagnostic accuracy, sensitivity, and specificity when clinicians used FX compared to unaided reading.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/9/2019
7 months - 2
FDA Approval
7/30/2020
Other devices from Imagen Technologies, Inc.
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