What Koios Medical does

Koios Medical, Inc. (formerly Clearview Diagnostics, founded 2011, headquartered in New York with a Chicago office) develops FDA-cleared and CE-marked AI-powered clinical decision support software for ultrasound-based cancer diagnosis. Its flagship products, Koios DS Breast and Koios DS Thyroid (marketed under the Smart Ultrasound® umbrella), use an ensemble of deep learning algorithms trained on a proprietary dataset of more than 500,000 ultrasound images contributed by 48+ research sites worldwide. The software analyzes over 17,000 features per image to classify lesions in real time, align outputs to BI-RADS or TI-RADS/ATA categories, and auto-populate diagnostic reports, with documented outcomes including up to 49% reduction in interpretation time, 20–30% fewer benign biopsies, and improved cancer detection rates.

The company distributes through a hybrid model combining OEM-embedded integration with Philips (EPIQ Elite and Affiniti via the Elevate Plus upgrade) and GE Healthcare (LOGIQ E10), vendor-neutral deployment through PACS workstations and the Harrison.ai Open Platform ecosystem, and direct enterprise sales to hospital systems, academic medical centers, and high-volume radiology practices (500+ installation sites). Revenue comes from volume-based annual subscriptions and billable CPT-coded procedures, following the company's Medicare reimbursement milestone. Strategic capital is led by Mitsui & Co. via its healthcare subsidiary MBK Healthcare Management, aligned with IHH Healthcare Berhad's 80-hospital network to support global expansion.

The team is small (early-30s headcount as of 2019), founder-led by CEO Chad McClennan and CFO/COO Graham Anderson, with William Hulbert as VP of Product Development. The company holds seven US patents plus patents in Australia, China, Japan, and the UK, and is pursuing regulatory clearances and clinical studies to broaden indications.

Name

Koios Medical

Legal name

Koios Medical, Inc.

Website

https://koiosmedical.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

Koios Medical develops FDA-cleared AI clinical decision support software (Koios DS Breast and Thyroid) that analyzes ultrasound images to help radiologists detect breast and thyroid cancer more accurately, sold to hospital systems and embedded in Philips and GE ultrasound platforms.

Ownership category

akta.pro rank

Product category

AI Clinical Decision Support Software for Medical Imaging

NAICS

Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345), Medical Equipment and Supplies Manufacturing (3391)

akta.pro primary industry

Medical Imaging AI (HDAAAEAH)

akta.pro secondary industries

AI Orchestration & Imaging Analytics Platforms (Model Management/Triage) (HLACALAG), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), Imaging Informatics & Workflow (PACS/RIS/VNA) (HLAHABAI), Radiology Reporting, Dictation & Structured Reporting (HLACALAF), Imaging & Diagnostic Interoperability (DICOM exchange, image sharing, VNA connectivity) (HLACABAM)

Keywords

• Clinical decision support
• Ultrasound AI software
• Breast cancer diagnosis
• Thyroid cancer detection
• Medical imaging AI

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. Software License (Annual/Subscription): Pricing based on annual diagnostic exam volume; provides software license for unlimited use by entire physician and technologist staff at a facility. This is a recurring subscription model.
2. Billable Procedure (CPT Codes): Koios DS is a billable procedure with assigned CPT codes, allowing healthcare providers to seek reimbursement for AI-assisted diagnostic services. The company has achieved reimbursement milestones alongside other notable radiology AI companies.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels7 records

Core offering

Koios Medical develops and sells Koios DS, an FDA-cleared and CE-marked AI-powered clinical decision support software for breast and thyroid cancer diagnosis using ultrasound images. The software analyzes over 17,000 features per image using ensemble deep learning algorithms trained on more than 500,000 proprietary ultrasound images, aligning outputs to BI-RADS (breast) and TI-RADS/ATA (thyroid) standards. The product is licensed to radiologists, hospitals, and radiology practices through annual subscription agreements and is also embedded directly into Philips and GE Healthcare ultrasound systems.

Differentiator

Problem solved

Functional benefit

Brands

• Smart Ultrasound: AI-powered software technology platform for breast and thyroid cancer diagnosis using ultrasound imaging, providing clinical decision support for radiologists.
• Koios DS
• Koios DS Breast
• Koios DS Thyroid

Products and services

• Koios DS Breast FDA-cleared and CE-marked AI-powered clinical decision support software for breast cancer diagnosis using ultrasound images. Trained on over 2 million proprietary ultrasound images and analyzes more than 17,000 features per image using ensemble deep learning algorithms. Classifies breast lesions and aligns to BI-RADS categories, providing real-time malignancy risk assessment to radiologists. Licensed on an annual subscription basis per facility with unlimited use by all physicians and technologists.
• Koios DS Thyroid AI-powered clinical decision support software for thyroid cancer diagnosis using ultrasound images. Analyzes over 17,000 features per image using proprietary deep learning algorithms to classify thyroid nodules and dynamically calculate malignancy risk aligned to TI-RADS or ATA reporting standards. Designed for endocrinologists and physicians performing thyroid ultrasound examinations. Licensed per facility with unlimited use by staff.
• Koios AI Breast Lesion and Thyroid Nodule Classification (On-Cart) Real-time on-cart AI decision support for breast lesion and thyroid nodule classification during ultrasound exams, available through Philips' Elevate Plus integration on EPIQ Elite and Affiniti systems. Enables radiologists to receive AI-assisted classification directly on the ultrasound cart during examinations, reducing interpretation time and supporting workflow efficiency.

Quantifiable outcome

• Up to 20-30% reduction in benign biopsies
• +7 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

AI capability3 records

Feature5 records

Partnerships

Five partnerships are on record, tiered core and strategic.

• PhilipscoreTechnology or Integration · 2 June 2026Philips integrated Koios AI decision support into its Elevate Plus software upgrade for EPIQ Elite and Affiniti ultrasound systems. Koios provides real-time breast lesion and thyroid nodule classification during ultrasound exams. This is the first on-cart integration, previously only available off-cart. The partnership reinforces Philips's leadership in AI-powered ultrasound.
• Harrison.aistrategicTechnology or Integration · 5 May 2026Koios was added to Harrison.ai's Open Platform ecosystem alongside AIRAmed, Lunit, and Nanox AI. The platform operates on open architecture with zero mark-ups, allowing healthcare providers to access AI solutions through vendor-neutral integration with existing PACS, RIS, and EHR systems. Harrison.ai has deployments at over 1,000 sites including 40+ NHS Trusts and serves half of Australian radiologists.
• Dr. Susan Love Research FoundationstrategicStrategic or Co-development Partner · 1 October 2016Collaborative research partnership for AI tool development for breast cancer diagnosis using low-cost, portable ultrasound imaging devices. This project was funded by a $4 million NIH/NCI grant and aimed to improve breast cancer detection in underserved populations.
• GE HealthcarecoreTechnology or IntegrationKoios DS Breast 2.0 is available connected to PACS and/or directly on GE Healthcare's LOGIQ E10 ultrasound system. This OEM partnership embeds Koios AI into GE's premium flagship ultrasound platform, making AI decision support available to GE Healthcare's extensive customer base.
• GE Healthcare (GE Health Cloud)strategicTechnology or IntegrationAs a GE Health Cloud Innovation Challenge winner, Koios was among the first ISVs to host its healthcare application on GE Healthcare's secure, scalable and connected cloud platform.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Lunit: Korea-based AI medical imaging company with FDA-cleared breast cancer detection products (Lunit INSIGHT MMG and DBT) and an ultrasound AI line. Closest direct competitor to Koios in breast cancer imaging AI; also a fellow member of the Harrison.ai open platform ecosystem.
• iCAD: Provides AI-based breast cancer detection and risk-stratification software (ProFound AI) used in mammography and DBT workflows. Direct competitor to Koios in AI-assisted breast imaging, with overlapping radiologist and breast-imaging specialist customer base.
• Volpara Health Technologies: Breast imaging analytics and AI software for density assessment, risk evaluation, and quality assurance. Comparable to Koios in its breast-imaging focus and SaaS/subscription delivery to hospital and imaging-center customers.
• ScreenPoint Medical: Developer of Transpara AI decision-support software for breast imaging (mammography, DBT, ultrasound). Closely comparable product category (AI breast lesion classification) and OEM/channel partnership strategy.
• Therapixel: French company behind MammoScreen 2.x, an FDA-cleared AI for mammography triage and detection. Comparable AI radiology product, similar customer segments (breast radiologists), and overlapping reimbursement pathway.
• Viz.ai: AI clinical decision support and workflow company with FDA-cleared products and Medicare reimbursement for stroke imaging. Peer in the radiology-AI reimbursement cohort alongside Koios, with similar SaaS-to-hospital GTM.
• HeartFlow: AI-driven cardiovascular diagnostics with Medicare reimbursement. Frequently cited alongside Koios in the radiology AI reimbursement cohort; comparable regulatory and reimbursement milestones and similar SaaS-plus-imaging economics.

Broad incumbents

• Aidoc: Broader-scope clinical AI platform covering CT, X-ray, and other modalities with hospital-wide workflow integration. A broader incumbent in radiology AI rather than a breast/ultrasound specialist, but increasingly competing for the same enterprise imaging budgets.
• Hologic: Major women's health imaging incumbent (mammography, ultrasound) with growing AI investments (e.g., Genius AI for DBT). Both a potential partner and competitor to Koios in breast imaging decision support, with substantially larger sales reach.
• Philips: Koios's largest OEM partner via the Elevate Plus integration on EPIQ Elite and Affiniti ultrasound. Also a broad incumbent in ultrasound imaging that could in-source competing AI capabilities over time, making it both a channel partner and a strategic risk.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds3 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Koios Medical