Vendor source
Reviewed 11 May 2026
Completeness Strong (75%)
General Information
Product name
ProFound AI for 2D Mammography
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
Other certifications
Not specified
Technical Specifications
Patient population age
Not specified
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
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
Population
Asymptomatic screening population
Market Presence
On market since
06-2019
AI Platforms
Blackford Analysis, CARPL.AI, deepc, GE Healthcare, Philips Healthcare, Sectra, Tempus
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 20, 2023 | Last updated: May 11, 2026