Vendor source

Reviewed 8 Oct 2026

Completeness Comprehensive (81%)

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

Supported by 7 papers

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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

Modality

Mammography

Main task

Not specified

Subspeciality

Breast

Disease targeted

Breast cancer

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

Technical Specifications

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

Population

Asymptomatic screening population

Market Presence

On market since

03-2018

Resellers

RMS Medical Devices

Countries present

25

Paying clinical customers

1300

Research/test users

30+

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Vendor | First published: Jun 9, 2024 | Last updated: Oct 8, 2026