BoneView by Gleamer is an AI-powered software that analyzes X-ray images of bones to detect and highlight fractures. It acts as a concurrent reading aid for clinicians, improving the accuracy and confidence of fracture diagnosis from radiographs across a wide range of anatomical areas. By providing clear visual annotations, it helps reduce missed fractures and supports better patient care.
Intended Use
BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of multiple anatomical areas such as ankle, foot, knee, wrist, ribs, spine, pelvis, and others. It is intended for concurrent use during radiograph interpretation by clinicians in adults.
Technology
BoneView uses supervised deep learning algorithms to process radiographic images received in DICOM format from imaging systems or PACS. It generates annotated images and summary tables marking regions of interest with bounding boxes indicating suspected or definite fractures. It can be deployed on-premises or in the cloud and integrates with clinical PACS and imaging systems via DICOM protocol without altering original images.
Performance
BoneView underwent extensive testing including standalone performance testing on 8,918 radiographs from various manufacturers, showing high sensitivity (up to 97%) and specificity (up to 93%) for fracture detection across multiple anatomical regions. A clinical reader study with 24 radiologists on 480 cases demonstrated significant improvements in diagnostic sensitivity (+10.4%) and specificity (+5%) when aided by BoneView versus unaided reading. No animal studies were conducted. Software verification and validation were performed per FDA guidance for moderate risk medical software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/30/2021
7 months - 2
FDA Approval
3/1/2022
Other devices from Gleamer
- BoneView2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.