Koios DS for Breast
Overview
Koios DS for Breast is an AI/machine learning-based computer-aided diagnosis (CADx) software device developed by Koios Medical. It is intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast cancer in adult female patients (>= 22 years) with soft tissue breast lesions. The software aids trained interpreting physicians in analyzing breast ultrasound images by automatically classifying lesions into ACR BI-RADS or European U1-U5 Classification System-aligned categories.
Built on an ensemble of algorithms trained with a proprietary dataset of over 2 million ultrasound images and analyzing over 17,000 features per image, Koios DS provides an AI/ML-derived cancer risk assessment. It also generates applicable lexicon-based descriptors to improve overall diagnostic accuracy and reduce interpreting physician variability. The software can also function as an image viewer for multi-modality digital images, including ultrasound and mammography, offering tools to adjust, measure, and document images, and output structured reports.
Koios DS for Breast integrates seamlessly into most PACS workstations, offering rapid deployment and an automated workflow that reduces manual data entry and physician fatigue. Clinical studies have demonstrated that Koios DS improves diagnostic accuracy, increases sensitivity and specificity, and can significantly reduce benign biopsy rates without missing cancers. It is also designed to be a reimbursement-eligible technology.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI/ML-based clinical decision support
- Aids in analysis of ultrasound images
- Classifies breast lesions into ACR BI-RADS or European U1-U5 categories
- Generates AI/ML-derived cancer risk assessment
- Provides lexicon-based descriptors
- Image viewer for multi-modality digital images (ultrasound, mammography)
- Tools for adjusting, measuring, documenting images, and structured reporting
- Seamless PACS integration
- Automated workflow, reduces manual data entry
- Real-time malignancy risk assessment
Use Cases
- Early and accurate breast cancer diagnosis
- Improving diagnostic accuracy for radiologists
- Reducing benign biopsy rates
- Reducing inter- and intraobserver variability in breast lesion assessment
- Automating reporting
- Enhancing workflow efficiency
What Physicians Need to Know
Koios DS for Breast serves as an AI-powered 'second opinion' to enhance diagnostic accuracy and reduce variability in breast ultrasound lesion assessment. Leverage its automated lesion classification and BI-RADS alignment to streamline reporting and improve consistency. The system's ability to reduce benign biopsies and potentially detect more cancers can significantly impact patient care and reduce unnecessary procedures. It is particularly beneficial for improving performance among less experienced readers and standardizing interpretations across different levels of expertise.
Koios DS is designed for broad compatibility, integrating with most major PACS platforms and directly with GE Healthcare's LOGIQ E10 Series, LOGIQ P-Series, and Invenia ABUS 2.0 ultrasound systems. This allows for flexible deployment at the point of care or connected to image viewers, facilitating seamless workflow integration and export of results to third-party reporting software.
Details
| Category | Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI |
| Pricing |
Subscription
|
| Deployment | On-premise (PACS integrated), Cloud (via partners) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Koios DS for Breast received 510(k) clearance (K190442) from the U.S. Food and Drug Administration on July 3, 2019, as a computer-assisted diagnostic software for lesions suspicious for cancer, intended as an adjunct to diagnostic ultrasound for breast cancer. |
| Integrations | |
| EHR | Not specified |
| Specialties | General Surgery, Oncology, Radiology |
What the Web Says
Koios DS for Breast is an AI-powered decision support tool designed to assist radiologists in breast cancer diagnosis. Reviews highlight its potential to improve diagnostic accuracy, reduce unnecessary biopsies, and standardize reporting, particularly for less experienced radiologists. While generally well-received, some discussions touch upon the integration challenges and the need for robust validation studies.
Overall: PositiveStrengths
- Aids in early and accurate breast cancer detection.
- Reduces false positives and unnecessary biopsies.
- Standardizes reporting and reduces inter-reader variability.
- Potentially improves efficiency in radiology workflows.
- Provides decision support for less experienced radiologists.
- Non-invasive and integrates with existing imaging modalities.
Limitations
- Integration challenges with existing PACS and EMR systems.
- Requires validation and trust from radiologists.
- Potential for over-reliance on AI by less experienced users.
- Cost of implementation and ongoing maintenance.
- Limited long-term outcome data in real-world settings.
- Data privacy and security concerns with AI platforms.
Based on reviews from: Koios Medical Website, Healthcare IT News, Radiology Today, AuntMinnie.com, PubMed (research articles), LinkedIn (professional discussions)
Last updated: 2026-07-18
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate Koios DS for Breast
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for Koios DS for Breast.
Dr. Amy Patel on Koios AI
Frequently Asked Questions
Compare Koios DS for Breast
VS
VS
VS
