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.

Product specifications

Information source: Vendor
Last updated: June 20, 2023

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)
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
Certification
CE	Certified, Class IIa , MDD
FDA	No or not yet
Market presence
On market since	06-2019
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
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)