intelliMammo™

Densitas

intelliMammo™ by Densitas Inc. is comprised of densitas densityai™, densitas qualityai™, and densitas riskai™, processes images automatically and generates results that are available on-demand both at point of care to radiological technologists and radiologists, and retrospectively at a clinic and health system level through an advanced analytics platform for radiologists, quality control technologists, diagnostic imaging managers and health system administrators.

densitas densityai™ provides ACR BI-RADS density scale assessments for development of consistent follow-up screening protocols.

densitas qualityai™ generates image quality evaluations consistent with the MQSA EQUIP and Canadian Association of Radiologists Mammography Accreditation Program image quality criteria.

densitas riskai™ provides breast cancer risk assessments based on image-derived factors and only two clinical factors.

Information source: Public
Last updated: May 26, 2022

General Information

General
Product name	intelliMammo™
Company	Densitas
Subspeciality	Breast
Modality	Mammography
Disease targeted	Breast cancer
Key-features	Breast density assessment, image quality assessment, risk score
Suggested use

Technical Specifications

Data characteristics
Population
Input
Input format
Output
Output format
Technology
Integration
Deployment
Trigger for analysis
Processing time

Regulatory

Certification
CE	Certified, Class unknown
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since	01-2017
Distribution channels	Blackford, Nuance PIN
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model
Based on

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers