ProFound AI for 2D Mammography
iCAD
|
Information source:
Vendor
Last updated: January 12, 2025 |
General Information
| General | |
|---|---|
| Product name | ProFound AI for 2D Mammography |
| Company | iCAD |
| Subspeciality | Breast |
| Modality | Mammography |
| Disease targeted | Breast cancer |
| Key-features | Malignancy detection, calcification detection, certainty scoring, case scoring |
| Suggested use | Before: adapting worklist order During: perception aid (prompting all abnormalities/results/heatmaps) |
Technical Specifications
| Data characteristics | |
|---|---|
| Population | Asymptomatic screening population |
| Input | full field 2D digital mammography |
| Input format | DICOM |
| Output | Leasion score with segmentation overlay, case score, choice in operating point (high/med/low) |
| Output format | DICOM Structured Report, GSPS, Secondary Capture |
| Technology | |
| Integration | Integration in standard reading environment (PACS), Stand-alone third party application |
| Deployment | Locally virtualized (virtual machine, docker) |
| Trigger for analysis | Automatically, right after the image acquisition |
| Processing time | 1 - 10 minutes |
Regulatory
| Certification | |
|---|---|
| CE |
Certified,
Class IIa
, MDD
|
| FDA | No or not yet |
| Intended Use Statements | |
| Intended use (according to CE) | iCAD ProFound AI for FFDM or 2D software is a computer-assisted detection and diagnosis (CAD) Artificial Intelligence (AI) software device intended to be used concurrently by interpreting physicians while reading 2D mammography exams from compatible 2D mammography systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in mammography images. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician. |
Market
| Market presence | |
|---|---|
| On market since | 06-2019 |
| Distribution channels | Tempus Pixel, RMS Medical Devices, Sectra Amplifier Store, GE, deepcOS and local Distributors |
| Countries present (clinical, non-research use) | 25 |
| Paying clinical customers (institutes) | 1300 |
| Research/test users (institutes) | 30+ |
| Pricing | |
| Pricing model | |
| Based on | |
Evidence
| Evidence | |
|---|---|
| Peer reviewed papers on performance |
|
| Non-peer reviewed papers on performance | |
| Other relevant papers |
|