OsteoDetect
Imagen Technologies
One of the earliest De Novo authorizations for a detection device. Analyzes wrist radiographs and marks suspected distal radius fractures for the reviewing clinician.
At A Glance
- Manufacturer
- Imagen Technologies
- Medical specialty
- Radiology
- Clearance route
- De Novo
- Year authorized
- 2018
- Modality
- X-ray
- Role in workflow
- Concurrent read
OsteoDetect was authorized as an adjunct, and the clinical scenario it addresses is not the radiologist. It is the emergency clinician reading a wrist film at two in the morning before a radiologist ever sees it. Missed distal radius fractures are common, consequential, and disproportionately occur in exactly that setting.
Where It Is Used
- Emergency department wrist radiograph review
- Fracture detection support for non-radiologist readers
Limitations Worth Knowing
The indication is a single fracture type at a single anatomical site. It does not detect other fractures on the same film, and a negative result carries no information about anything except the distal radius. Adjunct means the clinician remains the reader of record.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.