ProFound AI Risk

Key Features

  • Individual 1y/2y/3y breast cancer risk score

General Information

Product name

ProFound AI Risk

Company

Subspeciality

Breast

Modality

Mammography

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

Asymptomatic screening population

Patient population age

Not specified

Input

2D Mammography, 3D Digital Breast Tomosynthesis, age of patient

Input format

DICOM

Output

Risk score

Output format

DICOM SR, GSPS

Integration

Integration in standard reading environment (PACS), Stand-alone third party application

Deployment

Locally on dedicated hardware

Trigger for analysis

Automatically, Right after the image acquisition

Processing time

1 - 10 minutes

Regulatory Information

CE Certification

Pathway:

MDD

Class:

Class I

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

07-2020

AI Platforms

Blackford Analysis, Deepc, Sectra

Resellers

Icad inc, RMS Medical Devices

Countries present

-

Paying clinical customers

>1

Research/test users

>1

Pricing Information

Pricing model

Not specified

Based on

Not specified

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

European validation of an image-derived AI-based short-term risk model for individualized breast cancer screening—a nested case-control study

Peer-Reviewed

View

A risk model for digital breast tomosynthesis to predict breast cancer and guide clinical care

Peer-Reviewed

View

Identification of Women at High Risk of Breast Cancer Who Need Supplemental Screening

Source: vendor | First published: Dec 19, 2023 | Last updated: Jul 9, 2025