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Back to directoryiCAD ProFound AI medical AI product profile
Breast health AI suite for mammography detection, scoring, density assessment, and risk-related workflows.
Medical imaging and radiology
Best fit
Breast imaging programs comparing AI assistance for 2D mammography, digital breast tomosynthesis, case prioritization, and mammography workflow support.
- Primary use case
- AI-assisted breast cancer detection, mammography case scoring, density assessment, and short-term risk workflow support
- Audience
- Breast imaging centers, radiology groups, hospitals, and mammography programs
- Risk level
- High
- Pricing signal
- Enterprise breast-imaging pricing; verify current modules, clearances, viewer compatibility, and service terms.
- Official sources
- 5 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared ProFound Detection V4.0 computer-assisted detection and diagnosis software for digital breast tomosynthesis. |
|---|---|
| Review route | 510(k) K240417, with prior ProFound AI DBT clearances such as K203822. |
| Intended use | Used concurrently by interpreting physicians reading compatible DBT exams to identify soft-tissue densities and calcifications and provide certainty and case scores for physician review. |
| Verification note | Separate ProFound Detection, density, scorecard, risk, and regional modules; confirm version, compatible mammography systems, U.S. labeling, case-score display, and radiologist final-read responsibility. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf24 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating iCAD ProFound AI as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact ProFound module and version because FDA-cleared detection, density, and risk-related features do not share one blanket authorization. |
|---|---|
| Privacy | Review mammography image routing, DICOM metadata handling, PACS/viewer integration, cloud or local deployment, retention, access controls, and security documentation. |
| Evidence | Check reader-study evidence, breast-density subgroup performance, recall impact, cancer subtype detection, specificity, and whether priors are used in the selected version. |
| Workflow | Map where marks, case scores, density output, risk signals, and worklist prioritization appear in the radiologist workflow before clinical use. |
Where iCAD ProFound AI fits
iCAD describes ProFound breast-health AI for 2D and 3D mammography detection, density, scorecard, and risk-related workflows; its product and FDA-clearance materials distinguish cleared detection products from risk features that require product-specific status review.
Not for: Using risk, density, or detection claims interchangeably across products, geographies, exam types, or U.S. intended-use limits.
What to verify before using iCAD ProFound AI
- Which module is in scope: ProFound Detection, ProFound AI for DBT, density assessment, risk scoring, or another breast-health workflow.
- FDA clearance, CE mark, Health Canada status, and U.S. investigational limitations for the exact module and version.
- Compatibility with mammography vendor, PACS/viewer workflow, priors, worklist prioritization, and radiologist review process.
- Local performance across breast density, cancer subtype, recall rate, false positives, false negatives, and reading-time impact.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.icadmed.com / breast-health
- www.icadmed.com / profound-detection-v4-0
- www.icadmed.com / about / news-events
- www.accessdata.fda.gov / cdrh_docs / pdf24
- www.icadmed.com / wp-content / uploads
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