What NodeAI Diagnostics does

NodeAI Diagnostics Corp. is a Hamilton, Ontario-based medical device software company founded in late 2023 that develops AI-driven tools to improve lung cancer staging by enhancing ultrasound analysis during EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration) procedures. The company's platform addresses the clinical problem that approximately 40% of EBUS-TBNA procedures yield inconclusive or inaccurate staging results due to operator variability and the technical complexity of the procedure, leading to repeat biopsies and treatment delays. NodeAI is targeting healthcare institutions with bronchoscopy suites, thoracic surgeons and interventional pulmonologists, medical learners, and OEM partners who manufacture EBUS towers and processors.

The platform is built on nearly a decade of peer-reviewed research by co-founder and CMO Dr. Waël Hanna and is powered by a proprietary dataset of 3.2M+ ultrasound images and videos paired to pathology, described as one of the largest EBUS datasets in the world. The product suite comprises NodeAI OS (a platform foundation handling video ingestion, image storage, secure model serving, audit logging, and EMR integration, running on NVIDIA-powered edge hardware for bedside inference), NodeAI Guide (real-time lymph node detection and segmentation overlaid on live EBUS ultrasound), NodeAI Predict (per-node calibrated malignancy probability scoring), and NodeAI Analytics (cross-site benchmarking, training, credentialing, and procedure-volume forecasting). Validated performance on a 521-node held-out test set includes 96.91% specificity and an AUC of 0.701 for predicting malignancy from B-mode ultrasound images.

NodeAI is pre-commercial, operating as a research and evaluation platform with products undergoing multi-centre clinical trials (6 active sites with 9 more in activation across North America; ClinicalTrials.gov NCT06540196) and pursuing FDA 510(k) clearance. The planned revenue model is Software as a Medical Device (SaMD) delivered via subscription or licensing to healthcare institutions, with the go-to-motion combining direct enterprise field sales to hospitals and OEM partnerships. To date, the company has been funded exclusively through non-dilutive grants totalling approximately C$750K from FACIT, INOVAIT, and the Ontario Centre of Innovation, and has assembled board advisors including Prof. Kazuhiro Yasufuku (co-inventor of EBUS-TBNA) and Prof. Moishe Liberman.

Name

NodeAI Diagnostics

Legal name

NodeAI Diagnostics Corp.

Website

https://nodeai.ca

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

NodeAI Diagnostics is a Hamilton, Ontario-based medical device software company founded in 2023 that develops AI-driven real-time decision support for EBUS-TBNA lung cancer staging procedures, targeting hospitals, thoracic surgeons, and OEM partners.

Ownership category

akta.pro rank

Product category

Clinical Decision Support Software

NAICS

Scientific Research and Development Services (5417), Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372), Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Edge-Based Clinical Decision Support & Alerts (On-Device/On-Prem Analytics) (HLACAPAL)

akta.pro secondary industry

Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ)

Keywords

• Lung cancer diagnostics
• AI medical imaging
• EBUS guidance software
• Clinical decision support
• Cancer staging AI

Headquarters

HQ city

Hamilton

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Software as a Medical Device (SaMD): NodeAI is developing its platform as Software as a Medical Device. Currently operating as a research and evaluation platform. In future clinical deployments, the company will likely pursue subscription or licensing arrangements with healthcare institutions. The company states it may qualify as SaMD and is pursuing regulatory clearance.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

NodeAI develops an AI-powered software platform (Software as a Medical Device) that provides near-real-time decision support during EBUS-TBNA procedures for lung cancer staging. The platform delivers real-time lymph node detection and segmentation overlaid on live ultrasound, per-node malignancy probability scores, and cross-site benchmarking and reporting. It runs on an NVIDIA-powered edge device at the bedside, requiring no cloud dependency, and is designed to integrate with standard EBUS towers and processors without disrupting clinical workflow.

Product overview

NodeAI is a workflow-integrated AI platform for endoscopy-enabled care, consisting of one platform foundation (NodeAI OS) and three intelligent modules (NodeAI Guide, NodeAI Predict, and NodeAI Analytics). NodeAI OS serves as the platform layer handling video ingestion, image storage, secure model serving, audit logging, and EMR integration, running on an NVIDIA-powered edge device at the bedside. NodeAI Guide provides real-time lymph node detection and segmentation during EBUS procedures. NodeAI Predict delivers AI-powered per-node malignancy probability scores. NodeAI Analytics provides procedure benchmarking, training, and quality dashboards across connected sites.

Differentiator

Problem solved

Functional benefit

Products and services

• NodeAI OS NodeAI OS is the platform foundation that hosts all NodeAI modules. It handles video ingestion, image storage and reporting, secure model serving, audit logging, and EMR integration, running on an NVIDIA-powered edge device to deliver real-time analysis at the bedside. Engineered to medical device standards, it is intended for thoracic surgeons, interventional pulmonologists, and endoscopists performing EBUS-TBNA procedures in hospitals and bronchoscopy suites.
• NodeAI Guide NodeAI Guide performs real-time lymph node detection and segmentation overlaid directly on the live EBUS ultrasound image. As operators sweep through the mediastinum, target lymph nodes are detected, outlined, and tracked automatically, reducing operator variability across experience levels. It is intended for endoscopists and thoracic surgeons performing EBUS-TBNA procedures.
• NodeAI Predict NodeAI Predict is an AI-powered decision support module that returns a calibrated cancer risk score for each lymph node. It analyzes EBUS images and returns a per-node malignancy probability in seconds before the next biopsy decision, built on pathology-confirmed data. It is intended to assist endoscopists in biopsy targeting during EBUS-TBNA procedures.
• NodeAI Analytics NodeAI Analytics is a reporting and benchmarking layer that runs across every connected site. It provides procedure benchmarking, clinical training software, quality dashboards, scorecards, operator analytics, automated reports, case logs, credentialing infrastructure, and procedure-volume forecasting for healthcare institutions and clinical training programs.
• Canada Lymph Node Score (CLNS) The Canada Lymph Node Score (CLNS) is a 4-point ultrasonographic scoring system developed to assess malignancy risk in mediastinal lymph nodes during EBUS-TBNA, designed to standardize how endoscopists identify higher-risk targets for biopsy. It underpins NodeAI's clinical framework and is referenced in the platform's malignancy assessment logic.

Quantifiable outcome

• 96.91% specificity and AUC of 0.701 for predicting malignancy from B-mode EBUS ultrasound images
• +3 more outcomes

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability7 records

Feature5 records

Partnerships

Six partnerships are on record, tiered core and supporting.

• Prof. Moishe Liberman (Board Advisor)coreOthers · 22 October 2025Prof. Liberman is internationally recognized thoracic surgeon and educator, Director of Endoscopic Tracheobronchial and Oesophageal Center (C.E.T.O.C.) at CHUM, and Medical Director of CHUM's Multidisciplinary Robotic, Endoscopic, and Minimally Invasive Surgery Program. Joins as Advisor to Board providing guidance on medical and clinical research matters.
• Prof. Kazuhiro Yasufuku (Board Advisor)coreOthers · 14 October 2025Prof. Yasufuku is globally recognized leader in thoracic surgery and pioneering innovator in lung cancer diagnostics. Co-inventor of EBUS-TBNA procedure. Currently Head of Division of Thoracic Surgery and William Coco Chair in Surgical Innovation for Lung Cancer at University Health Network (UHN). Joins as Advisor to Board providing strategic guidance on lung cancer staging, surgical innovation, and minimally invasive diagnostics.
• McMaster UniversitycoreStrategic or Co-development PartnerFounding team originated from McMaster University where Dr. Waël Hanna serves as Division Head of Thoracic Surgery. Company based in Hamilton, Ontario near McMaster Innovation Park. Represents academic-clinical partnership underpinning technology development.
• McMaster Innovation ParksupportingStrategic or Co-development PartnerNodeAI is part of Hamilton's growing life sciences cluster operating out of or near McMaster Innovation Park. Several of the 10 LSIF recipients are based in Hamilton with operations at MIP.
• TIAP (Toronto Institute for Advanced Learning)supportingStrategic or Co-development PartnerListed as part of NodeAI's innovation ecosystem supporting the company's development.
• St. Joseph's ResearchsupportingStrategic or Co-development PartnerListed as part of NodeAI's innovation ecosystem supporting the company's development and clinical research.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Market position

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/nodeai-corp

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds1 record

Investors1 record

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 NodeAI Diagnostics