ProFound AI for Digital Breast Tomosynthesis

iCAD

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Key Features

Calcification detection
Case scoring
Certainty scoring
Malignancy detection

General Information

Product name

ProFound AI for Digital Breast Tomosynthesis

Company

iCAD

Subspeciality

Breast

Modality

Mammography

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

Asymptomatic screening population

Patient population age

Not specified

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

Integration

Integration in standard reading environment (PACS), Provides case score in worklist when applicable, 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 IIa

Verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

03-2018

AI Platforms

Deepc, GE Healthcare, Sectra, Tempus

Resellers

RMS Medical Devices

Countries present

Paying clinical customers

1300

Research/test users

30+

Pricing Information

Pricing model

Not specified

Based on

Not specified

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

Retrospective comparison between single reading plus an artificial intelligence algorithm and two-view digital tomosynthesis with double reading in breast screening

Technical Papers

Technical

View

Artificial Intelligence for Digital Breast Tomosynthesis - Reader Study Results

Source: vendor | First published: Jun 9, 2024 | Last updated: Jul 10, 2025