Optellum Secures TGA Approval to Expand AI-Enabled Lung Nodule Solution To Australia
OXFORD, England, Feb. 26, 2026 /PRNewswire/ -- Optellum, the leading AI-enabled solution for earlier lung cancer detection, is thrilled to announce that it has received Therapeutic Goods Administration (TGA) class IIb approval in Australia for the Virtual Nodule Clinic (VNC) platform to support early lung cancer diagnosis. 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 pulmonary 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 over 15,000 new diagnoses each year and low 5-year survival rates around 27%. [1] Delayed detection of incidental findings, inconsistent follow-up, and growing pressure on imaging and specialist services continue to contribute to later diagnosis. These pain points can lead to unnecessary anxiety for patients and missed opportunities for earlier intervention, highlighting the need for tools that support timely recognition and coordinated health systems.
This TGA clearance poises Optellum to help thousands of patients in Australia by supporting earlier and more consistent identification of incidental lung nodules. By helping care teams prioritize higher-risk findings and streamline follow-up more efficiently, VNC aims to reduce delays and uncertainty along the lung cancer care pathway. This clearance marks an important step in bringing validated AI tools into everyday clinical workflows, without replacing clinical judgment.
Optellum remains committed to working with Australian health systems to support responsible AI adoption that improves patient care quality and experience. 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 early diagnosis and treatment of lung disease, starting with one of the deadliest, lung cancer.
Optellum's flagship product, Virtual Nodule Clinic (VNC) with Lung Cancer Prediction AI (LCP), is the world's first and only FDA-cleared and reimbursed software-as-a-medical-device (SaMD) solution for AI-powered lung cancer prioritization and diagnostic support. Clinicians trust the Optellum solution to aid them in making the most appropriate life-saving treatment decisions for their patients. Backed by real-world clinical evidence, Optellum's solution accelerates the diagnostic care pathway by enabling early patient identification, enhancing prioritization, and improving clinicians' efficiency, reducing time to guideline-recommended treatment. Optellum VNC is FDA cleared, CE-MDR marked, TGA approved, and UKCA marked.
Optellum is headquartered in Oxford, UK, and has an office at the Texas Medical Center in Houston, Texas, US.
[1] https://www.canceraustralia.gov.au/cancer-types/lung-cancer/lung-cancer-australia-statistics
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