About
Koios Medical is a healthcare AI company specializing in AI-powered clinical decision support (CDS) software for ultrasound-based cancer diagnosis. Their flagship product, Koios DS™, is FDA-cleared and CE marked, placing it among the most credentialed AI tools in medical imaging and enabling its use as a reimbursable billable procedure. The platform offers two specialized modules: Koios DS™ Breast and Koios DS™ Thyroid. Both leverage deep learning and machine learning trained on data contributed by 48 research sites across multiple countries to provide physicians and sonographers with real-time diagnostic recommendations and risk stratification directly from ultrasound images. Koios DS integrates into existing radiology workflows without disrupting standard clinical processes, making adoption practical for hospitals, breast imaging centers, and endocrinology practices. Clinical evidence demonstrates that the software measurably reduces missed cancers, including invasive lobular carcinomas, directly improving patient survival outcomes. The company has attracted institutional investment from Mitsui & Co., validating both its clinical value and global commercial potential. Koios Medical is ideal for radiology departments, breast imaging specialists, and thyroid care teams seeking to enhance diagnostic accuracy, reduce false negatives, and modernize their cancer screening workflows with proven AI assistance.
Key Features
- AI-Powered Breast Cancer Detection: Koios DS™ Breast analyzes ultrasound images using machine learning to provide risk stratification and diagnostic guidance for breast lesions, significantly reducing missed cancers.
- Thyroid Nodule Analysis: Koios DS™ Thyroid assists clinicians in evaluating thyroid nodules on ultrasound, improving diagnostic confidence and consistency in thyroid cancer detection.
- FDA-Cleared & CE Marked: Koios DS meets US and European regulatory standards and qualifies as a billable procedure, ensuring clinical-grade reliability and institutional reimbursability.
- Seamless Workflow Integration: Designed to fit within existing radiology and clinical workflows, Koios DS delivers AI-generated insights at the point of care without disrupting standard processes.
- Globally Validated AI Model: The AI is trained and validated on data from 48+ international research sites, providing a robust, clinically credible model for cancer risk assessment across diverse patient populations.
Use Cases
- Radiologists leveraging AI to analyze breast ultrasound images and reduce false negatives in cancer screening programs.
- Endocrinologists and thyroid specialists using AI-assisted decision support to evaluate thyroid nodules for malignancy risk.
- Hospital radiology departments implementing FDA-cleared AI tools to improve cancer detection rates and standardize reporting quality.
- Breast imaging centers adopting Koios DS to reduce missed invasive lobular carcinomas and improve patient survival outcomes.
- Healthcare institutions seeking clinically validated, reimbursable AI software to meet quality benchmarks in cancer diagnostics.
Pros
- Regulatory Approval: FDA 510(k) clearance and CE marking make Koios DS one of the most credentialed AI medical imaging tools available, enabling legal clinical use and reimbursement.
- Clinically Proven Accuracy: Studies show the software reduces missed cancers and achieves strong performance even with challenging cancer types like invasive lobular carcinoma.
- Billable Reimbursement: As a billable procedure, healthcare institutions can offset adoption costs through reimbursement, making the ROI case straightforward.
- Broad Global Validation: Data contributions from 48 research sites across multiple countries lend strong multi-institutional evidence to the platform's diagnostic capabilities.
Cons
- Narrow Anatomical Scope: Currently limited to breast and thyroid ultrasound analysis, restricting application to specific specialties rather than broad radiology or multi-organ imaging.
- Enterprise-Focused Deployment: Designed for hospitals and clinical institutions, making it largely inaccessible to independent practitioners or small clinics without formal installation infrastructure.
- Integration and Setup Requirements: Requires IT involvement for installation and integration with existing imaging systems, which may add onboarding time and complexity.
Frequently Asked Questions
What is Koios DS?
Koios DS is an FDA-cleared, CE-marked AI software platform that analyzes ultrasound images to provide clinical decision support for breast and thyroid cancer diagnosis, helping physicians make faster and more accurate assessments.
Is Koios DS FDA approved?
Yes. Koios DS has received 510(k) clearance from the FDA and is also CE marked for use in Europe, meeting stringent regulatory requirements for AI-based medical devices.
Which types of cancer does Koios DS support?
Koios DS currently supports breast cancer diagnosis through Koios DS™ Breast and thyroid cancer evaluation through Koios DS™ Thyroid, both using ultrasound image analysis.
Can Koios DS be billed as a medical procedure?
Yes. Koios DS qualifies as a billable procedure, allowing healthcare providers to seek reimbursement for its use within a patient's diagnostic workflow.
How does Koios DS integrate into clinical workflows?
Koios DS is engineered to integrate with existing ultrasound equipment and radiology systems, providing AI-generated diagnostic recommendations at the point of care without significantly disrupting established clinical processes.
