breastscape® v1.0

Olea Medical
breastscape contains 2 different applications: BreastApp and BreastLoc
BreastApp: Semi automatic solution to aid breast lesion diagnosis in MRI with dedicated viewing tools, automatic lesion detection and BI-RADS report integration.
BreastLoc: MRI Breast biospy diagnostic tool. All the catalog of grids and needles available within the application.
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Information source: Vendor
Last updated: February 7, 2022

General Information

General
Product name breastscape® v1.0
Company Olea Medical
Subspeciality Breast
Modality MR
Disease targeted Breast cancer
Key-features Lesion segmentation and volumetry, DCE and ADC quantification, lesion follow-up, BI-RADS report, ACR classification, guidances for breast biopsy
Suggested use

Technical Specifications

Data characteristics
Population all patients for Breast MRI analysis
Input All series from MRI examination including morphologic and functionnal sequences (DCE, DWI). Mammography and US modalities can be loaded for examination comparison.
Input format DICOM
Output BI-RADS Report, DCE, DWI computation maps, lesion segmentation overlay
Output format DICOM-PDF or secondary capture (report), DICOM (imaging)
Technology
Integration Integration in standard reading environment (PACS), Stand-alone third party application
Deployment Locally on dedicated hardware, Locally virtualized (virtual machine, docker)
Trigger for analysis On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time BreastLoc: <3 sec, BreastApp: 1 - 10 minutes

Regulatory

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

Market

Market presence
On market since 06-2018
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model Subscription
Based on Number of users

Evidence

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