Subscribe to our monthly newsletter Subscribe

ProFound AI for 2D Mammography

iCAD

Designed for radiologists, ProFound AI™ for 2D Mammography analyzes each image, detecting both malignant soft tissue densities and calcifications.

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	Using artificial intelligence in the diagnosis of breast cancer: First results after implementation in a radiology department of a breast clinic (read)
Non-peer reviewed papers on performance
Other relevant papers	Comparison of Mammography AI Algorithms with a Clinical Risk Model for 5-year Breast Cancer Risk Prediction: An Observational Study (read)