FractureDetect (FX)
Overview
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device developed by Imagen Technologies. It leverages robust scientific principles and industry-standard deep learning algorithms for computer vision to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX analyzes adult radiographs and provides relevant annotations, creating a DICOM overlay that indicates the presence or absence of fractures. This overlay can be toggled on or off within the clinician’s PACS viewer, allowing for uninhibited concurrent review of the original radiograph. The device is specifically indicated for adults only and supports various industry-standard radiographic views and study types across the musculoskeletal system, including areas like the ankle, clavicle, and other upper and lower extremities, and pelvis.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Computer-assisted detection and diagnosis (CAD) for fractures
- Utilizes deep learning algorithms for image analysis
- Analyzes musculoskeletal radiographs in adults
- Provides relevant annotations and DICOM overlays
- Indicated for adults only
- Supports multiple radiographic views and study types (e.g., ankle, clavicle, pelvis, upper/lower extremities)
- Improves clinician diagnostic accuracy and confidence
- Reduces missed fractures in clinical settings
- Seamlessly integrates into existing PACS workflows
Use Cases
- Assisting clinicians in detecting fractures during radiograph review at the point of care
- Improving diagnostic accuracy for various clinician types, including radiologists, emergency medicine physicians, and primary care physicians
- Reducing diagnostic errors and misinterpretations in emergency departments
- Enhancing clinician experience and productivity by streamlining diagnostic workflows
- Enabling earlier detection and intervention for musculoskeletal fractures
- Supporting in-office imaging solutions within primary care and other practices
What Physicians Need to Know
FractureDetect (FX) serves as a valuable assistive tool, particularly beneficial for clinicians with varying levels of experience in musculoskeletal imaging. Leverage the AI-generated DICOM overlays as a 'second reader' to enhance diagnostic confidence and reduce the likelihood of missed fractures, especially subtle ones. Remember that the overlay can be toggled on/off, allowing for uninhibited review of the original image. Integrate the AI's findings into your diagnostic process, but always maintain clinical judgment as the final arbiter. The tool's ability to improve diagnostic accuracy and potentially speed up reporting can significantly impact patient care and workflow efficiency in busy settings.
FractureDetect (FX) is designed for seamless integration into existing radiology workflows by adhering to DICOM standards. It functions as a DICOM node, receiving studies from PACS and returning annotated images as DICOM overlays or new series. This 'Pull-Process-Push' method ensures compatibility with most PACS environments with minimal configuration, leveraging your current DICOM infrastructure without disrupting performance. This allows for the AI's insights to be presented directly within the radiologist's familiar viewing environment.
Details
| Category | Radiology & Imaging AI |
| Pricing | Contact for pricing — Contact sales for custom pricing. |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated FractureDetect (FX) received 510(k) FDA clearance (K193417) on July 30, 2020. It is cleared as a computer-assisted detection and diagnosis (CAD) software device intended to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system in adults. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Orthopedics, Radiology |
What the Web Says
FractureDetect (FX) by Imagen is an FDA-cleared AI-powered software designed to assist clinicians in detecting musculoskeletal fractures in adult radiographs. It analyzes X-rays and provides annotations to highlight potential fractures, aiming to reduce diagnostic errors, particularly in emergency departments where missed fractures are common. Clinical studies have shown that FractureDetect improves the diagnostic accuracy of clinicians, especially those with limited musculoskeletal imaging training, by significantly reducing missed fracture rates.
Overall: PositiveStrengths
- High sensitivity and specificity in fracture detection.
- Significantly improves diagnostic accuracy for clinicians, including those with limited training.
- Reduces missed fracture rates (e.g., 45% relative reduction in one study).
- Provides DICOM overlays with annotations, which can be toggled on/off.
- Covers a wide range of musculoskeletal areas and radiographic views.
- FDA-cleared for clinical use.
Limitations
- Intended for adults only (22 years and older).
- Not intended to replace the clinician's review and judgment.
- Potential for over-reliance on AI and deskilling of healthcare professionals.
- Some AI solutions have shown a decline in performance on external data.
- Diagnostic accuracy may be lower for spine and rib fractures (general AI limitation, not specific to FX).
- Concerns about liability when using AI software (general AI concern).
Based on reviews from: Imagen Technologies, Inc. (FDA 510(k) Clearance Application), AJR Special Series on AI Applications: Artificial Intelligence (AI) for Fracture Diagnosis: An Overview of Current Products and Considerations for Clinical Adoption, Imagen AI Software, PMC: Deep Learning Assistance Closes the Accuracy Gap in Fracture Detection Across Clinician Types, BJR|Open: Commercially available artificial intelligence tools for fracture detection: the evidence, AJR Online: Artificial Intelligence (AI) for Fracture Diagnosis: An Overview of Current Products and Considerations for Clinical Adoption, F, Reddit (r/Radiology, r/artificial, r/technology, r/legaladvice), PMC: Artificial intelligence in commercial fracture detection products: a systematic review and meta-analysis of diagnostic test accuracy, Oxford Academic: Commercially available artificial intelligence tools for fracture detection: the evidence
Last updated: 2026-07-18
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