Frequently Asked Questions
About NodeAI
What is NodeAI? NodeAI is a medical artificial intelligence company developing a workflow-integrated AI platform for endoscopy-enabled care, with an initial focus on endobronchial ultrasound (EBUS) lymph node staging in lung cancer. NodeAI's platform provides real-time lymph node detection and segmentation, per-node malignancy prediction, and automated procedure analytics, all running on a bedside edge device.
Who founded NodeAI? NodeAI was founded in 2023 by Dr. Waël Hanna, a thoracic surgeon, alongside co-founders Mackensey Bacon (Chief Executive Officer) and Anthony Gatti (Chief Technology Officer). Dr. Hanna serves as President and Chief Medical Officer.
Where is NodeAI headquartered? NodeAI Diagnostics Corp. is headquartered at 175 Longwood Road S #113, Hamilton, Ontario, L8P 0A1, Canada.
What is NodeAI's tagline? NodeAI's product tagline is "Augment Beyond.”
The Clinical Problem
What is EBUS-TBNA? Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is the current gold standard procedure for mediastinal lymph node staging in non-small cell lung cancer (NSCLC). It uses an ultrasound-equipped bronchoscope to visualize lymph nodes in the chest and to guide a needle biopsy through the airway wall.
Why is lymph node staging important in lung cancer? Lymph node staging determines whether cancer has spread beyond the lung and directly informs treatment decisions, including whether a patient is a candidate for surgical resection, chemotherapy, radiation, or combination therapy. Inaccurate staging can lead to inappropriate treatment selection and worse patient outcomes.
What problem does NodeAI solve? Approximately 40% of EBUS-TBNA procedures yield inconclusive or inaccurate results due to operator variability and the technical complexity of the procedure. This contributes to repeat biopsies, treatment delays, and increased healthcare costs. NodeAI provides real-time AI guidance during the procedure to standardise lymph node detection, segmentation, and malignancy assessment across operators of varying experience levels.
How common are EBUS-TBNA procedures? EBUS-TBNA is performed more than 270,000 times annually in North America alone. The global lung cancer diagnostics market is projected to reach approximately $6.6 billion USD by 2030.
The NodeAI Platform
What is the NodeAI platform? NodeAI is a workflow-integrated AI platform for endoscopy-enabled care. It consists of one platform foundation (NodeAI OS) and three intelligent modules (NodeAI Guide, NodeAI Predict, and NodeAI Analytics).
What is NodeAI OS? NodeAI OS is the platform foundation that hosts every NodeAI module. It handles video ingestion, image storage and reporting, secure model serving, audit logging, and EMR integration. NodeAI OS is engineered to medical device standards, runs on an NVIDIA-powered edge device for real-time bedside analysis, hosts the Guide, Predict, and Analytics modules in one platform, and supports remote access on any device.
What is NodeAI Guide? NodeAI Guide is the in-procedure module that performs real-time lymph node detection and segmentation, overlaid directly on the live EBUS ultrasound image. As the operator sweeps through the mediastinum, target lymph nodes are detected, outlined, and tracked automatically. Guide is designed to reduce operator variability across experience levels and augment operator skill in the moment.
What is NodeAI Predict? NodeAI Predict is an AI-powered decision support module that returns a calibrated cancer risk score for each lymph node. The operator captures a still frame and NodeAI Predict analyses the EBUS image and returns a per-node malignancy probability in seconds, before the next biopsy decision. NodeAI Predict has a reported area under the curve (AUC) of 0.84.
What is NodeAI Analytics? NodeAI Analytics is the 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 space, staffing, and scheduling.
How is NodeAI deployed? NodeAI is deployed on an all-in-one edge device that sits beside the bronchoscopy tower and connects directly to the EBUS video feed. Inference runs locally on the edge device. NodeAI does not require a cloud connection or external server for procedural use, which supports fast, reliable, real-time results at the bedside.
Is NodeAI compatible with my existing EBUS equipment? Yes. NodeAI is designed to be compatible with standard EBUS towers and processors. The platform is vendor-agnostic and integrates with existing hospital workflows.
Is NodeAI a replacement for the clinician? No. NodeAI is a clinical decision support adjunct that augments operator performance and integrates with physician judgement. All clinical decisions remain with the treating physician.
Who NodeAI Is For
Who benefits from NodeAI? NodeAI delivers value across every audience the EBUS suite serves: patients, learners, endoscopists, institutions, and original equipment manufacturers (OEMs).
How does NodeAI benefit patients? NodeAI is designed to support the highest quality lung cancer staging by reducing operator variability and standardising the diagnostic process.
How does NodeAI benefit learners and trainees? Through NodeAI Analytics, learners gain access to simulation training, instructional videos, scorecards, benchmarking against peers, and case logs.
How does NodeAI benefit endoscopists? Endoscopists use Guide, Predict, and Analytics together to augment skill level and clinical decisions in real time, generate automated procedure reports, access scorecards and benchmarking, maintain case logs and procedure videos, and support maintenance of certification.
How does NodeAI benefit institutions? Healthcare institutions use NodeAI to increase EBUS procedure volumes, automate reporting, support billing infrastructure, build research infrastructure, and run quality improvement (QI) and credentialing programs.
How does NodeAI benefit OEMs? For original equipment manufacturers, NodeAI supports increased processor and consumable sales, AI system integration, and access to user data, institutional data, and research and QI infrastructure.
Regulatory and Clinical Evidence
Is NodeAI FDA-cleared? No. The company is pursuing 510(k) clearance for its product suite.
Is NodeAI being studied in clinical trials? Yes. NodeAI is the subject of a multi-centre clinical trial evaluating the safety and feasibility of the platform for real-time prediction of mediastinal lymph node malignancy during EBUS staging for lung cancer. The trial is registered on ClinicalTrials.gov under identifier NCT06540196.
What clinical performance has NodeAI reported? NodeAI Predict is currently undergoing internal testing, with formal clinical validation planned ahead of regulatory submission. Validated performance metrics will be reported upon completion of our multi-reader validation study.
Where can I find published research on NodeAI? Information on NodeAI's clinical research program is available on the company's Research page.
Data Privacy and Security
How does NodeAI handle patient data? NodeAI is engineered to medical device standards, with secure model serving, audit logging, and EMR integration. Procedural inference is performed locally on the bedside edge device. NodeAI complies with applicable health privacy regulations, including Ontario's Personal Health Information Protection Act (PHIPA). Full details are available in the NodeAI Privacy Policy.
Contact
How can I contact NodeAI? NodeAI can be contacted by email at info@nodeai.ca. The company is headquartered at 175 Longwood Road S #113, Hamilton, Ontario, L8P 0A1, Canada.