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Optellum, an Oxford-based lung health company aiming to redefine early diagnosis and treatment of lung disease, has received FDA clearance for its AI-powered clinical decision support software.

Lung cancer kills more people globally than any other cancer. The current five-year survival rate is only 20%, primarily due to the majority of patients being diagnosed after symptoms have appeared and the disease has progressed to an advanced stage. Optellum was co-founded by Oxford cancer researcher Professor Sir Michael Brady with the mission of seeing every lung disease patient diagnosed and treated at the earliest possible stage, when chances of cure are the highest.

Optellum’s initial product is the Virtual Nodule Clinic, the first AI-powered Clinical Decision Support software for lung cancer early diagnosis cleared by the FDA. Pulmonary nodules are small growths in the lung that can be detected, often incidentally, using a computed tomography (CT) scan. Current guidelines mandate follow-up over one to two years to determine whether a nodule is cancerous and various, sometimes invasive and unnecessary, procedures may also occur before a definitive diagnosis is reached.

Optellum’s much-needed platform helps clinicians identify and track at-risk patients with suspicious lung nodules and make optimal clinical management decisions. The software features a clinically validated Lung Cancer Prediction (LCP) score designed to empower clinicians to more accurately and consistently evaluate lung cancer risk and make more optimal clinical decisions that could save patient lives. The LCP score was recently externally validated in a multi-centre study as part of a National Institute for Health Research i4i programme, IDEAL, led by Professor Fergus Gleeson (Department of Oncology).


This clearance will ensure clinicians have the clinical decision support they need to diagnose and treat lung cancer at the earliest possible stage, harnessing the power of physicians and AI working together – to the benefit of patients. Our goal at Optellum is to redefine early diagnosis and treatment of lung cancer, and this FDA clearance is the first step on that journey. We look forward to empowering clinicians in every hospital, from our current customers at academic medical centers to local community hospitals, to offer patients with lung cancer and other deadly lung diseases the most optimal diagnosis and treatment. - Dr Václav Potěšil, co-founder and CEO of Optellum

Read more in the Optellum press release

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