ProFound AI for Digital Breast Tomosynthesis

iCAD
The concurrent-read, cancer detection and workflow solution from iCAD analyzes each tomosynthesis image, detecting both malignant soft tissue densities and calcifications.
Built on deep-learning and artificial intelligence technology, ProFound AI for breast tomosynthesis assists radiologists in addressing the challenges of reading tomosynthesis.

Formerly branded as PowerLook Tomo Detection 2.0
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Information source: Vendor
Last updated: June 9, 2024

General Information

General
Product name ProFound AI for Digital Breast Tomosynthesis
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 3D Digital Breast Tomosynthesis
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, Provides case score in worklist when applicable
Deployment Locally on dedicated hardware
Trigger for analysis Automatically, right after the image acquisition
Processing time 1 - 10 minutes

Regulatory

Certification
CE
Certified, Class IIa , MDD
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) ProFound AI® Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. 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 03-2018
Distribution channels Tempus Pixel, RMS Medical Devices, Sectra Amplifier Store, GE 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

  • Patient Characteristics Impact Performance of AI Algorithm in Interpreting Negative Screening Digital Breast Tomosynthesis Studies (read)

  • Using artificial intelligence in the diagnosis of breast cancer: First results after implementation in a radiology department of a breast clinic (read)

  • Retrospective comparison between single reading plus an artificial intelligence algorithm and two-view digital tomosynthesis with double reading in breast screening (read)
Non-peer reviewed papers on performance

  • Artificial Intelligence for Digital Breast Tomosynthesis - Reader Study Results (read)
Other relevant papers