Transpara
ScreenPoint Medical
Analyzes 2D mammography and tomosynthesis, marking suspicious regions and assigning both a region score and an exam-level score intended to support reading and workload triage.
At A Glance
- Manufacturer
- ScreenPoint Medical
- Medical specialty
- Radiology
- Clearance route
- 510(k)
- Year authorized
- 2018 onward
- Modality
- Mammography and tomosynthesis
- Role in workflow
- Concurrent read
Transpara has been studied more heavily in European double-reading programs than in the United States, because those programs have a specific question worth answering: can software replace one of two required human readers. That is a workforce question as much as a clinical one, and it does not translate cleanly to a single-reader system.
Where It Is Used
- Screening mammography interpretation support
- Second-reader replacement studies in double-reading programs
- Workload reduction by exam score stratification
Limitations Worth Knowing
Evidence generated in organized national screening programs does not automatically transfer to opportunistic screening with different recall thresholds, different equipment, and different population risk. Score thresholds that safely reduce workload in one program can be unsafe in another.
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.