Products

Koios DS for Breast
Koios Medical
Clinical Decision Support & Reference
Koios DS for Breast is an FDA-cleared, AI-powered clinical decision support software that assists radiologists in the early and accurate diagnosis of breast cancer from ultrasound images, improving accuracy and workflow efficiency.
Koios DS
Koios Medical
Oncology AI
Koios DS is an AI-powered clinical decision support software by Koios Medical, assisting physicians in analyzing breast and thyroid ultrasound images for cancer diagnosis, improving accuracy, and streamlining workflows.

See all 2 products →

About Koios Medical

Koios Medical is a healthcare AI company that develops advanced software solutions for radiologists, primarily focused on enhancing diagnostic accuracy and workflow efficiency in cancer detection through ultrasound imaging. Their flagship products, Koios DS Breast and Koios DS Thyroid, also known as Smart Ultrasound™, utilize proprietary artificial intelligence and deep machine learning algorithms. These algorithms have been trained on extensive datasets, including over 500,000 ultrasound images of breast lesions linked to pathology results, and a broader dataset exceeding 2 million ultrasound images for their Smart Ultrasound™ platform.

For physicians, Koios Medical’s technology acts as an intelligent, on-demand second opinion, providing real-time, evidence-based clinical decision support. This support aims to improve diagnostic confidence, speed up clinical decisions, and significantly reduce the rate of unnecessary biopsies (by up to 20% fewer benign biopsies) while simultaneously increasing the detection rate of cancers (by up to 5% more cancers caught). The software is FDA-cleared and CE Mark approved, ensuring regulatory compliance and clinical utility. It can be seamlessly integrated into existing Picture Archiving and Communication Systems (PACS) or deployed directly on ultrasound scanners, thereby streamlining reporting and overall workflow. The company is also actively expanding its deep learning platform to address other disease areas, including lung, prostate, and skin cancer, underscoring its commitment to transforming diagnostics across multiple medical specialties.

Focus Areas

AI-powered clinical decision support ultrasound image analysis breast cancer diagnosis thyroid cancer diagnosis radiology machine learning deep learning computer vision

Business Intelligence

Key InvestorsMitsui & Co. (MBK Healthcare Management), Daiwa JPI Alternative Investments, New Age Ventures, Bold Brain Capital, National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering, BITKRAFT Ventures, Brighter Capital, Electric Capital, Ethereal Ventures, Hartmann Capital, Mercury Fund, MetaProp Ventures, Polygon, Third Prime, Jutta Steiner, Matias Woloski, Maya Zehavi, Scott Belsky, Teck Chia
PartnershipsGE Healthcare, Philips, RamSoft, iCAD, Sirona Medical
TechnologyAI algorithms, machine learning, deep learning, computer vision, ensemble of algorithms, proprietary dataset (over 2 million ultrasound images), vendor-agnostic, PACS integration
FDA Clearances4 cleared products (estimated)

What Physicians Need to Know

AI-Powered Clinical Decision Support
Koios Medical specializes in AI-driven software, Koios DS (Decision Support), that assists physicians in interpreting ultrasound images for cancer diagnosis.
Ultrasound Image Analysis
Their core expertise lies in analyzing ultrasound images for the detection and characterization of lesions and nodules.
Breast Cancer Diagnosis
Koios DS Breast is an FDA-cleared and CE-marked solution for early and accurate breast cancer diagnosis using AI-powered ultrasound.
Thyroid Cancer Diagnosis
Koios DS Thyroid provides AI-based decision support for the early and accurate diagnosis of thyroid cancer from ultrasound exams.
Advanced AI/ML Technologies
The company leverages deep machine learning, computer vision, and advanced AI algorithms to process and interpret medical images.
Physician Tip

Koios Medical's 'SmartUltrasound' platform offers physicians an 'expert on-demand second opinion' to enhance diagnostic accuracy and confidence, especially in challenging cases. It significantly reduces interpretation time and automates reporting, freeing up valuable clinical time and combating physician burnout. The technology is proven to reduce unnecessary biopsies for breast lesions (up to 31%) and helps avoid unwarranted fine needle aspirations for thyroid nodules, leading to better patient outcomes and reduced healthcare costs. Furthermore, its alignment with established reporting guidelines like BI-RADS, TI-RADS, and ATA ensures standardized and consistent assessments. The availability of CPT Category 3 codes makes the use of Koios DS a billable procedure.

Koios DS software is designed for seamless integration into most PACS workstations, supporting DICOM protocols for smooth communication within existing radiology workflows. It can be deployed on-site as an ASP.NET web application on an IIS Web Server with a Windows operating system and SQL Server. The software is also integrated into specific ultrasound systems, such as GE Healthcare's LOGIQu2122 E10. Strategic partnerships, like those with iCAD and RamSoft, expand its reach by offering comprehensive, multi-modality AI suites for breast cancer detection and integrated cloud-based RIS/PACS solutions. Koios DS is compatible with major ultrasound hardware manufacturers, ensuring broad applicability.

Products by Koios Medical

2 products in the directory

Koios DS for Breast
Koios Medical
Clinical Decision Support & Reference
Koios DS for Breast is an FDA-cleared, AI-powered clinical decision support software that assists radiologists in the early and accurate diagnosis of breast cancer from ultrasound images, improving accuracy and workflow efficiency.
Koios DS
Koios Medical
Oncology AI
Koios DS is an AI-powered clinical decision support software by Koios Medical, assisting physicians in analyzing breast and thyroid ultrasound images for cancer diagnosis, improving accuracy, and streamlining workflows.

What the Web Says

Koios Medical develops AI-powered software, Koios DS, for clinical decision support in diagnosing breast and thyroid cancer using ultrasound. The software has received FDA clearance and is designed to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline radiologist workflows. While there is extensive information on their product's efficacy and features, public reviews specifically from G2, Glassdoor, Capterra, or Reddit regarding employer experiences or direct product user opinions are limited or not readily available.

Overall: Positive

Strengths

  • Improved accuracy in breast and thyroid cancer diagnosis
  • Reduced unnecessary benign breast biopsies (by up to 37-70%)
  • Increased thyroid cancer detection rates (up to 14%)
  • Decreased interpretation variability among physicians (over 50%)
  • Streamlined workflow and reduced time spent per case (by up to 24%)
  • FDA-cleared and CE Marked, with alignment to ACR BI-RADS and TI-RADS systems

Limitations

  • Limited public employee or product user reviews on major platforms (G2, Glassdoor, Capterra, Reddit)
  • No readily available information on potential drawbacks or challenges from user perspectives

Based on reviews from: Elion, Fierce Biotech, Applied Radiology, Koios Medical Official Website, FirstWord HealthTech, TestDynamics

Last updated: 2026-07-18

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Press & Coverage

Startup Intros
Koios Medical: Funding, Team & Investors | Startup Intros
Koios Medical has raised a total of $15.95 million in funding, including an $8.0M Series B round in January 2023. The company develops AI-based clinical decision support software for diagnosing breast and thyroid cancers from ultrasound imaging.
2023-01
Unknown
Healthcare Private Placement and M&A Transactions Review Week Ending June 2, 2024
Koios Medical raised $130 million of venture funding in the form of convertible debt from undisclosed investors on May 28, 2024. The company develops an ultrasound image analysis platform for early disease detection and diagnosis.
2024-05
Imaging Technology News
Koios Medical, iCAD Work to Expand AI-Powered Breast Cancer Detection | Imaging Technology News
Koios Medical and iCAD, Inc. announced a strategic reseller partnership on February 26, 2025, to deliver a comprehensive, multi-modality AI suite for breast cancer detection. This collaboration integrates iCAD's ProFound AI Breast Health Suite for mammography with Koios SmartUltrasound.
2025-02
Hckonnect
Koios Medical SmartUltrasoundTM Joins HCK's TEO MultiLink Network Expanding the Reach of AI-Powered Ultrasound Diagnostics, Enriching the Offering for Partners & Customers | Hckonnect
On March 24, 2026, Koios Medical joined HCK's TEO MultiLink Network, a collaboration hub connecting AI companies to cross-sell and co-distribute solutions to over 3,500 healthcare organizations worldwide. Koios DS platform uses AI algorithms trained on over 3 million ultrasound images for real-time cancer risk assessments.
2026-03
PR Newswire
RamSoft Partners with Koios Medical to Provide Integrated AI-Powered Software for Breast and Thyroid Cancer Diagnosis - PR Newswire
RamSoft Inc. announced a new distributorship agreement with Koios Medical on September 25, 2025, to integrate Koios's AI-powered Smart Ultrasoundu2122 software into RamSoft's cloud-native RIS/PACS platforms for breast and thyroid cancer detection and diagnosis.
2025-09
PMC (PubMed Central)
Investigation of artificial intelligenceu2013based clinical decision support system's performance in reducing the fine needle aspiration rate of thyroid nodules: A pilot study - PMC
A pilot study published in December 2024 evaluated the clinical impact of Koios Decision Supportu2122 on the diagnostic performance of ultrasound assessment of thyroid nodules, aiming to reduce fine needle aspiration rates. The study found that Koios DS suggested avoidable fine needle aspiration in 53% of benign cases.
2024-12
AuntMinnie
Koios ultrasound AI software gets FDA clearance - AuntMinnie
The U.S. Food and Drug Administration (FDA) cleared Koios Medical's Koios DS, an AI-based software platform for diagnosing thyroid and breast cancer, on December 16, 2021. The software was developed using ultrasound data from 48 sites globally to aid physicians in diagnosis and reduce avoidable surgeries.
2021-12
FierceBiotech
AI, digital health feature in latest batch of FDA breakthrough device designations
Koios Medical received FDA breakthrough device designation in May 2021 for its AI software designed for early detection of breast and thyroid cancer. The software analyzes ultrasound images to help radiologists determine if a biopsy is needed, aiming to prevent unnecessary biopsies and improve cancer detection rates.
2021-05

Frequently Asked Questions

Koios Medical's flagship products are Koios DSu2122 Breast and Koios DSu2122 Thyroid, which are AI-powered software platforms designed for clinical decision support in ultrasound image analysis. These solutions assist physicians in the early and accurate diagnosis of breast and thyroid cancer by providing malignancy risk assessments.
Koios Medical's Smart Ultrasoundu2122 software utilizes deep learning and computer vision algorithms, trained on over 2 million proprietary ultrasound images, to analyze more than 17,900 features per image. This AI provides an expert on-demand second opinion, classifying lesions with greater precision, aligning to BI-RADSu00ae or TI-RADSu00ae categories, and automating reporting, which significantly improves diagnostic accuracy and streamlines radiologists' workflow.
Koios Medical's Koios DSu2122 Breast and Koios DSu2122 Thyroid software are both FDA-cleared and CE Marked, allowing for widespread use in diagnostic settings. The company has received multiple FDA clearances, including the latest SmartUltrasoundu2122 Decision Support (DS) Software Version 3.6, demonstrating its commitment to regulatory compliance and product advancement.
Koios Medical operates on a Software-as-a-Service (SaaS) model, offering annual subscription pricing that is tailored to customer size and usage, from individual physicians to large enterprise integrations. They also provide a low-risk, low-cost risk and revenue-sharing pricing model, along with multi-year enterprise contracts to facilitate scalability across health systems.
Koios DS software is designed for seamless integration into most PACS workstations and can also be deployed directly on ultrasound scanners. It supports DICOM protocol and allows findings to be exported to any reporting system or saved as a secondary capture to PACS, ensuring compatibility and efficient workflow. Koios Medical provides customer support and resources for activation and product documentation.
Yes, Koios Medical has established strategic reseller partnerships with major healthcare technology firms such as GE Healthcare, Philips, RamSoft, and iCAD. These collaborations enable broader distribution of Koios's AI software, facilitate integration into existing imaging platforms and ultrasound systems, and expand the reach of their multi-modality AI solutions for cancer detection.
Koios Medical, established in 2007 and formally focused on medical AI since 2017, demonstrates strong company stability with significant funding, including $130 million in venture funding in May 2024 and a total of $143.00M raised to date. The company has a growing global presence, trusted in over 1,000 hospitals and clinics across more than 30 countries, including over 50% of the top 30 cancer centers in the U.S.

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