ProFound AI
iCAD
A concurrent-read detection and case-scoring tool for digital breast tomosynthesis. Marks suspected soft tissue densities and calcifications and assigns a certainty score to each finding and to the case overall.
At A Glance
- Manufacturer
- iCAD
- Medical specialty
- Radiology
- Clearance route
- 510(k)
- Year authorized
- 2018
- Modality
- Digital breast tomosynthesis
- Role in workflow
- Concurrent read
Concurrent read is a meaningfully different category from triage. The software marks the image while the radiologist reads it, which means it is influencing interpretation rather than ordering a queue. That places a higher burden on the reader to understand the failure modes, because an unmarked region carries an implicit and unearned reassurance.
Where It Is Used
- Screening tomosynthesis interpretation
- Reading time reduction in high-volume screening
- Case prioritization by risk score
Limitations Worth Knowing
Reader studies supporting concurrent-read devices measure performance in controlled conditions with prepared readers and enriched case sets. Real screening populations have far lower disease prevalence, which lowers positive predictive value regardless of how well the model performed in the study. Automation bias is the documented risk: readers can under-call findings the software did not mark.
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.