OXFORD, England, February 27, 2026 /PRNewswire/ — Optellum, the leading AI-based solution for early detection of lung cancer, is excited to announce that it has received Class IIb approval from the Therapeutic Goods Administration (TGA) in Australia for the Virtual Nodule Clinic (VNC) platform to support early diagnosis of lung cancer. This important regulatory milestone was achieved after a rigorous review of technical documentation and validation studies, recognizing its safety and performance for clinical use. VNC helps identify, triage and manage patients with lung nodules and includes a clinically validated AI decision support tool, Lung Cancer Prediction (LCP) AI, already used in the US and EU/UK for nodule risk stratification.
Lung cancer remains a major health challenge in Australia, with more than 15,000 new diagnoses each year and low 5-year survival rates of around 27%. [1] Delayed detection of incidental findings, inconsistent follow-up and increasing pressure on imaging and specialist services continue to contribute to later diagnosis. These issues can lead to unnecessary patient anxiety and missed opportunities for earlier intervention, highlighting the need for tools that enable rapid recognition and coordinated health systems.
This TGA clearance allows Optellum to help thousands of patients in Australia by enabling earlier and more consistent identification of incidental lung nodules. By helping care teams prioritize higher-risk outcomes and streamline follow-up more effectively, VNC aims to reduce delays and uncertainty throughout the lung cancer care journey. This authorization marks an important step in integrating validated AI tools into daily clinical workflows, without replacing clinical judgment.
Optellum remains committed to working with Australian health systems to support the responsible adoption of AI that improves the quality and experience of patient care. This milestone reflects Optellum’s broader mission to help patients move from detection to diagnosis with speed, greater clarity and confidence.
About Optellum
Optellum is a commercial-stage AI healthcare company dedicated to revolutionizing the early diagnosis and treatment of lung diseases, starting with one of the deadliest lung cancers.
Optellum’s flagship product, Virtual Nodule Clinic (VNC) with Lung Cancer Prediction AI (LCP), is the world’s first and only software-as-a-medical-device (SaMD) solution approved and reimbursed by the FDA for AI-powered lung cancer prioritization and diagnostic assistance. Clinicians trust the Optellum solution to help them make the most appropriate treatment decisions to save the lives of their patients. Backed by real-world clinical evidence, Optellum’s solution accelerates the diagnostic care journey by enabling early patient identification, improving prioritization and improving clinician efficiency, thereby reducing the time to guideline-recommended treatment. Optellum VNC is FDA approved, CE-MDR marked, TGA approved and UKCA marked.
Optellum is headquartered in Oxford, United Kingdom, and has an office at the Texas Medical Center in Houston, Texas, United States.
[1] https://www.canceraustralia.gov.au/cancer-types/lung-cancer/lung-cancer-australia-statistics
Media contact
marketing@optellum.com
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SOURCEOptellum
