Hospital AI platform

medical imagingmachine learningviewer

Overview
AI-powered, end-to-end suite of modular, interoperable breast imaging screening and diagnostic workflow applications designed to integrate into existing IT and radiology workflows. Improves diagnostic accuracy, workflow efficiency and standardization of care across mammography, tomosynthesis, ultrasound and associated review workflows.

Included applications / modules

• ProFound Pro (AI-powered detection and localization)
• Breast Density (automated density assessment)
• Safeguard Review (AI-assisted second-review workflow)
• Risk Assessment (AI-driven short-term risk prediction)
• BAC (breast analytics & case prioritization)
• DeepHealth Viewer (viewer integration)
• Mammography Insights (analytics and reporting)
• Breast Ultrasound (automated US analysis and standardized worksheets)

Key capabilities

• Intelligent prioritization: automatically flags and prioritizes exams by suspicion level to speed turnaround and enable same-day follow-up.
• AI-powered Safeguard review workflow: supports second-reader workflows to reduce false negatives and highlight likely-missed or hard-to-detect cancers.
• Automated density assessment: consistent, automated density classification for 2D and 3D mammograms to support objective clinical decisions.
• Risk assessment: identifies patients at higher short-term risk (1–2 years) based on imaging for targeted supplemental screening.
• Automated ultrasound analysis: lesion detection and characterization with auto-populated BI-RADS–aligned ultrasound worksheets.
• Intelligent reporting: auto-populated reporting elements to standardize and streamline documentation.
• Quality analytics: monitoring, compliance support and large-scale quality improvement dashboards.
• Modular deployment and interoperability: designed to integrate with existing PACS/RIS and deployment infrastructures.

Clinical impact & performance highlights

• Reported increases in cancer detection rate (CDR): examples shown on page include 9.4% increased CDR (DM 2D), 21% increased CDR (DBT/3D) and Breast Suite aggregate improvements in detection metrics in published/real-world studies.
• Equitable impact reported across populations: examples include up to 23% more cancers detected in women with dense breasts and 20% more cancers detected in Black / African American women in cited studies.
• Supports faster case flagging and review: rapid image processing and case flagging (example metrics reported for integrated deployments with selected vendor systems).

Regulatory & evidence

• Clinical evidence and peer-reviewed publications and conference presentations referenced on the product page (multiple citations and an evidence booklet are provided by the manufacturer).
• Some components reference FDA 510(k) clearance(s) and clinical performance testing; other components are CE-marked for the EU market; some functionalities and the ultrasound module are pending regulatory clearance in specific markets (see manufacturer disclaimers).

Deployment & integration

• Designed for integration into existing diagnostic workflows (PACS/RIS) and supports modular adoption (deploy individual components or the full suite).
• Works with priors and multi-modality imaging (2D, DBT/3D, ultrasound) and supports viewer integration for streamlined radiologist workflow.

Characteristics / technical specifications

• Manufacturer / Brand: DeepHealth
• Product name / commercial designation: Breast Suite
• Modular components: ProFound Pro, Breast Density, Safeguard Review, Risk Assessment, BAC, DeepHealth Viewer, Mammography Insights, Breast Ultrasound
• Imaging modalities supported: 2D mammography (DM), digital breast tomosynthesis (DBT/3D), breast ultrasound
• Primary functions: cancer detection & localization, automated density classification, risk prediction, case prioritization, automated reporting, ultrasound lesion detection and BI-RADS worksheet generation, quality analytics
• Clinical evidence: multiple peer-reviewed publications, clinical performance testing and real-world deployment studies cited by the manufacturer (see evidence booklet)
• Regulatory notes: CE marked for EU market for some functionalities; select component(s) reference FDA 510(k) clearance(s); some modules (e.g., breast ultrasound) pending FDA 510(k) clearance or market availability in specific countries
• Documented improvements (examples): increased cancer detection rates and improved detection in dense-breast and specific demographic cohorts as reported in cited studies
• Delivery: modular AI suite integrated with existing IT (PACS/RIS/viewer) and designed for scalable population health and screening workflows