Koios DS Breast is software that assists trained interpreting physicians in analyzing breast ultrasound images. The core AI engine characterizes image features to generate output that aligns to BI-RADSĀ® ATLAS* categories (Benign, Probably Benign, Suspicious, Probably Malignant). The engine also classifies on the basis of shape and orientation. The software exports results to third-party reporting software. Time to generate and present results for two analyzed ROIs is <= 2 seconds.
Product specifications Information source: Vendor
Last updated: March 17, 2022
General
Product name Koios DS Breast
Company Koios Medical, Inc.
Subspeciality Breast
Modality Ultrasound
Disease targeted Breast cancer
Key-features BI-RADS categorization, lesion classification, confidence level indicator, smart calipers, one-click diagnosis
Suggested use During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion
Data characteristics
Population Women with lesions suspicious for breast cancer - Not for Pediatric use
Input Ultrasound images
Input format DICOM images
Output BI-RADS Categorization and Classifiers, Shape, Orientation, Confidence Level Indicator, Position, Size
Output format Web application https, DICOM C-Store, MagView, Nuance, etc.
Technology
Integration Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform, Integrated on ultrasound scanner
Deployment Locally virtualized (virtual machine, docker), Cloud-based, On scanner
Trigger for analysis On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time < 3 sec
Certification
CE
Certified, Class IIa , MDD
FDA
510(k) cleared, Class II
Market presence
On market since 03-2018
Distribution channels Nuance, MagView, 3M MModal, PenRad, GE Healthcare, all major PACS
Countries present (clinical, non-research use) 20+
Paying clinical customers (institutes) 28+
Research/test users (institutes) 13+
Pricing
Pricing model Subscription, Activation Fee
Based on Number of users, Number of analyses
Evidence
Peer reviewed papers on performance

  • Impact of Data Presentation on Physician Performance Utilizing Artificial Intelligence-Based Computer-Aided Diagnosis and Decision Support Systems (read)

  • Should we ignore, follow, or biopsy? Impact of artificial intelligence decision support on breast ultrasound lesion assessment (read)

Non-peer reviewed papers on performance

  • RSNA 2020 - Mango - Decreasing Benign Breast Ultrasound Biopsies: Prospective Use of AI Decision Support (read)

  • SIIM2021.org - Barinov - Improving the Efficacy of TI-RADS Through Artificial Intelligence (read)

  • SBI ACR Breast Imaging Symposium 2020 - Cavallo - AI Analysis of Ultrasound Images Could Decrease Benign Breast Biopsies (read)

Other relevant papers