Optellum Virtual Nodule Clinic

by Optellum Ltd.  · Based in United Kingdom → — The lung health company
Oncology Pulmonology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Optellum Virtual Nodule Clinic (VNC) is an AI-powered clinical decision support software designed to assist pulmonologists and radiologists in the early diagnosis and optimal management of patients with pulmonary nodules, which may represent early-stage lung cancer. It aims to redefine early diagnosis and treatment of lung disease by providing a comprehensive platform for discovering, tracking, and assessing the risk of malignancy in lung nodule patients. The software integrates seamlessly with existing Electronic Health Record (EHR) and Picture Archiving and Communication System (PACS) using standard protocols like HL7 and DICOM, enabling automated retrieval of patient information, reports, and images without disrupting clinical workflows. VNC leverages advanced AI, including a clinically validated Lung Cancer Prediction (LCP) score, to analyze CT images and provide a user-friendly cancer risk score, outperforming standard-of-care models. It also includes Patient Discovery AI to automatically identify patients with detected nodules from radiology reports and offers dedicated workflow management with incidental and screening dashboards and patient timelines.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered Lung Cancer Prediction (LCP) score for malignancy risk assessment
  • Patient Discovery AI to identify nodules from radiology reports using NLP
  • Workflow management system with incidental and screening dashboards
  • Patient tracking and management timelines
  • Seamless EHR and PACS integration (HL7, DICOM)
  • Automated data and report retrieval
  • Clinically validated risk stratification and decision support
  • Web application access via standard desktop web browsers
  • Zero-click Lung Cancer Prediction (zcLCP) for automated analysis
  • Full auditability and detailed logging capabilities

Use Cases

  • Early lung cancer diagnosis
  • Lung nodule management and follow-up
  • Risk assessment of malignancy in incidentally detected pulmonary nodules
  • Prioritizing at-risk lung nodule patients
  • Reducing time to diagnosis for lung cancer
  • Improving guideline-concordant follow-up rates for detected nodules

What Physicians Need to Know

Evidence Base
Optellum Virtual Nodule Clinic (VNC) is an FDA-cleared, Medicare-reimbursable, UKCA, CE-MDR marked, and TGA approved AI solution for lung nodule management. It is built on robust scientific and clinical evidence, with publications in leading journals and collaborations with top academics. The Lung Cancer Prediction (LCP) AI consistently outperforms standard-of-care models like Brock and Mayo. Studies indicate AI models are significantly more sensitive than physician judgment alone (15.8%) and clinical risk models alone (35.4%), with superior relative AUCs.
Clinical Validation Studies
FDA clearance was supported by a clinical study demonstrating a statistically significant improvement in diagnostic accuracy for pulmonologists and radiologists, with an average improvement of 6.85 Area Under the Curve (AUC) points (p<0.001). Recent clinical evidence (December 2025) published in BMJ Open Respiratory Research and presented at ESMO AI & Digital Oncology Congress highlights that VNC significantly accelerates time to diagnosis and improves follow-up rates. A retrospective study showed guideline-concordant follow-up for detected nodules increased from 34% to 94% in an AI-enabled workflow, and median time to diagnosis of non-small cell lung cancer was reduced from 129 days to 25 days. A US multi-center ambispective study is evaluating real-world implementation at 14 sites, with interim results showing substantial improvements in patient identification and follow-up. A lifetime payer study (March 2026) found AI-supported clinician risk stratification to be cost-effective and associated with improved life expectancy.
Alert Fatigue Management
The system incorporates a comprehensive notification system to ensure patients receive necessary follow-ups. It issues alerts if a patient misses a scheduled CT scan to help maintain optimal care pathways. Patient Discovery AI automatically identifies patients with reported lung nodules, flagging them for prompt clinical review, and workflow management dashboards aid in triage and tracking.
Override Rate Data
Specific override rate data is not explicitly provided. The Optellum Virtual Nodule Clinic functions as a clinical decision support tool, providing a Lung Cancer Prediction (LCP) score and risk stratification to enhance clinician decision-making and consistency, rather than dictating a final action. The ultimate management decision rests with the physician.
Differential Diagnosis Support
The Lung Cancer Prediction (LCP) AI provides a nodule-specific cancer risk score, indicating the probability of malignancy. This score categorizes malignancy risk on a decile scale (1-10), assisting clinicians in characterizing incidentally detected pulmonary nodules and determining which require further testing versus those that are likely benign, thereby avoiding unnecessary procedures.
Guideline Update Frequency
The tool is designed to support and facilitate adherence to published clinical guidelines for lung nodule assessment. It helps address the challenge of patients not receiving guideline-recommended follow-up. While the frequency of internal guideline updates within the software is not specified, its core function is to align with and improve compliance with current clinical recommendations.
Clinical Workflow Integration
Optellum VNC seamlessly integrates with existing hospital Electronic Health Record (EHR) and Picture Archiving and Communication Systems (PACS) using standard protocols like HL7 and DICOM. It automates the retrieval of patient information, reports, and images without disrupting current clinical workflows, operating as an intelligent layer. The system is compatible with major EHRs (e.g., EPIC, Oracle Cerner) and requires no changes to how radiologists or pathologists document findings, minimizing redundant data entry and logins. It includes dedicated workflow management dashboards for triage, tracking, and patient timelines, which nurse navigators have praised for ease of use and seamlessness.
Decision Audit Trail
The platform offers full auditability and detailed logging capabilities across all system activities. This functionality supports robust governance, regulatory compliance, and effective change management within the clinical environment.
Physician Tip

Leverage Optellum Virtual Nodule Clinic to streamline the identification and risk stratification of pulmonary nodules, particularly incidental findings, to ensure timely and guideline-concordant follow-up. Utilize the Lung Cancer Prediction (LCP) score as a validated input to enhance diagnostic accuracy and inform management decisions, potentially reducing unnecessary invasive procedures for benign nodules and accelerating diagnosis for malignant ones. Integrate the system's automated tracking and alert features to minimize lost-to-follow-up cases and improve overall patient navigation within multidisciplinary lung nodule programs. Remember that the AI provides decision support, augmenting your clinical judgment, not replacing it.

Optellum Virtual Nodule Clinic is designed for seamless integration with existing hospital IT infrastructure, including EHR (e.g., Epic, Oracle Cerner) and PACS systems, via industry-standard protocols (HL7, DICOM). This 'intelligent layer' approach minimizes disruption to current clinical workflows, requiring no changes to documentation practices and offering automated data retrieval. The system's interoperability supports efficient patient discovery, image analysis, and report aggregation, enhancing multidisciplinary team collaboration and tumor board preparation.

Details

Category Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Reimbursable under CMS New Technology APC
  • The American Medical Association (AMA) issued Category III CPT® codes (0721T) effective July 1, 2022, for services related to the utilization of Optellum Lung Cancer Prediction AI
  • Medicare payment assignment for CPT code 0721T was $650.50 in 2025
DeploymentOn-premise or private cloud options within hospital datacenter.
Compliance
BAA Available Yes AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Received FDA 510(k) clearance (K202300) on March 5, 2021, for Optellum™ Virtual Nodule Clinic, Optellum™ Software, and Optellum™ Platform. It is classified as a Class II device under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Integrations
EHR Not specified
Specialties Oncology, Pulmonology, Radiology

What the Web Says

Optellum Virtual Nodule Clinic (VNC) is an AI-powered clinical decision support software designed to assist physicians in the early diagnosis and management of lung nodules, which can be early signs of lung cancer. It has received FDA clearance, CE-MDR, UKCA approval, and Medicare reimbursement, making it a recognized solution in the US, UK, and Europe. The platform integrates patient discovery AI, workflow management dashboards, and Lung Cancer Prediction (LCP) AI to identify, track, and assess the malignancy risk of lung nodules.

Overall: Positive

Strengths

  • Improves diagnostic accuracy and consistency for lung nodule malignancy assessment across all levels of physician experience.
  • Accelerates time to diagnosis for lung cancer and improves follow-up rates for detected nodules.
  • Reduces unnecessary invasive procedures for benign nodules and avoids treatment delays for malignant ones.
  • Automates the detection of lung nodules in radiology reports, ensuring at-risk patients are not lost to follow-up.
  • Provides a user-friendly cancer risk score (LCP AI) that outperforms standard-of-care models.
  • Demonstrated to be cost-effective from a US payer perspective, with improved life expectancy.

Limitations

  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra, suggesting a niche market or early adoption stage.
  • The LCP CNN algorithm is not currently validated for screening studies.
  • Requires integration with existing EHR and PACS systems, which can be a complex process.
  • While improving consistency, it's still a decision support tool and not a replacement for clinical judgment.
  • Potential for over-reliance on AI if not used in conjunction with clinical expertise.

Based on reviews from: Elion, Optellum (Press Releases/Blog), Wikipedia, Atrium Health Wake Forest Baptist, G2, PR Newswire, PubMed Central (PMC), accessdata.fda.gov, ClinicalTrials.gov

Last updated: 2026-07-19

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Press & Coverage

Optellum
Optellum Celebrates Accelerating Impact in Lung Cancer Care; Now at Over 250 Clinical Deployments
Optellum announced it has surpassed 250 clinical deployments of its AI-enabled lung cancer diagnostics, highlighting its accelerating impact in lung cancer care.
2026-06
Business Wire
Tanner Health and Healthliant Ventures Partner With Optellum to Bring AI for Lung Health to the Region
Tanner Health and Healthliant Ventures have partnered with Optellum to launch the Virtual Nodule Clinic, an AI platform designed to assist care teams in managing potentially cancerous lung nodules.
2026-06
Optellum
NHS Greater Glasgow and Clyde leads new study using AI to improve lung cancer diagnosis
NHS Greater Glasgow and Clyde is leading a new study, SWIFT-Lung, in collaboration with Optellum and other institutions, to evaluate the integration of Optellum's Virtual Nodule Clinic AI system for earlier lung cancer diagnosis.
2026-06
Optellum
Optellum AI Shown to be Highly Cost-Effective in First US Lifetime Payer Study of Lung Nodule Risk Stratification
A study led by Vanderbilt University Medical Center researchers found Optellum's FDA-cleared Lung Cancer Prediction AI to be cost-effective from a US payer perspective for risk stratification of indeterminate pulmonary nodules.
2026-03
Optellum
Optellum Announces New Clinical Evidence Demonstrating the Real-World Impact of AI on Lung Cancer Care
Optellum announced new clinical evidence, published in BMJ Open Respiratory Research and presented at ESMO AI & Digital Oncology Congress, demonstrating its Virtual Nodule Clinic significantly accelerates time to diagnosis and improves follow-up rates for lung cancer patients.
2025-12
PR Newswire
Optellum Announces Agreement with Bristol Myers Squibb to Leverage AI to Boost Early Lung Cancer Diagnosis
Optellum has partnered with Bristol Myers Squibb to leverage AI in early diagnosis and precision lung cancer care, applying its AI-powered platform to evaluate real-world impact on patient outcomes.
2025-04
Optellum
Transforming lung cancer diagnosis: Optellum's AI-powered Virtual Nodule Clinic at Atrium Health
Atrium Health Wake Forest Baptist is utilizing Optellum's AI-powered Virtual Nodule Clinic to enhance early lung cancer diagnosis and treatment, and to assess cancer risk with greater confidence.
2025-01
PR Newswire
Optellum showcases AI-powered precision lung interventions at AABIP 2024
Optellum showcased how its Virtual Nodule Clinic AI, combined with advanced robotics and imaging, can enable precision biopsy and improve patient outcomes at the American Association of Bronchology and Interventional Pulmonology (AABIP) 2024 Annual Conference.
2024-08

Videos

Product demos, reviews, and walkthroughs for Optellum Virtual Nodule Clinic.

View all on YouTube

Frequently Asked Questions

The Optellum Virtual Nodule Clinic integrates with a hospital's Electronic Health Record (EHR) and Picture Archiving and Communication Systems (PACS) using standard protocols like HL7 and DICOM. It automatically retrieves patient information, radiology reports, and CT images to identify and track lung nodules, providing a dashboard for clinicians to manage patient care without altering existing workflows.
The system provides an AI-powered Lung Cancer Prediction (LCP) score, which analyzes 3D CT images to indicate the risk of a nodule being cancerous on a decile scale. Studies have shown that using the Optellum software significantly improves diagnostic accuracy for pulmonologists and radiologists in classifying indeterminate pulmonary nodules.
Optellum Virtual Nodule Clinic has received FDA 510(k) clearance in the US (2021) and CE-MDR and UKCA clearance in Europe and the UK (2022), making it the first AI decision support for early lung cancer diagnosis with such broad regulatory approval. For data privacy, protected health information (PHI) remains within the hospital's control, either on-premise or in a private cloud, ensuring HIPAA compliance.
Optellum's AI-powered LCP score has been shown to consistently outperform conventional risk prediction models, such as Brock and Mayo, recommended in current clinical guidelines. It aims to reduce delayed treatment for cancer patients and minimize unnecessary invasive procedures on benign nodules by providing enhanced risk stratification.
In the UK, a license for the Virtual Nodule Clinic costs u00a322,500 per year, with education pricing available. In the US, the Lung Cancer Prediction AI is reimbursable under CMS New Technology APC, with a national payment rate of approximately $650.50 per use under specific Category III CPT codes (0721T, +0722T) for hospital outpatient facilities.
The Optellum LCP Score is not indicated for patients with a history of cancer less than 5 years, those with more than five pulmonary nodules, pure Ground-Glass Opacities (GGO), calcified nodules, or thoracic implants impacting image appearance. It is also not indicated for patients younger than 35 years or for nodules detected solely by lung cancer screening studies.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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