{"entity":{"id":"optellum-virtual-nodule-clinic","kind":"drug","name":"Optellum Virtual Nodule Clinic","aka":[],"tldr":"The first AI cleared to estimate how likely a lung nodule on a CT scan is to be cancer, helping doctors decide who needs a biopsy and who can wait.","summary":"Optellum (Oxford, UK) received FDA 510(k) clearance in March 2021 for the Virtual Nodule Clinic, the first AI decision-support software for lung cancer diagnosis, and is CE-marked. The LCP score was validated on the NLST and other cohorts and, in reader studies, improved clinicians' discrimination of benign from malignant nodules; the product is used in NHS trusts and US health systems to run nodule clinics and to prioritise early biopsy of high-risk nodules. As lung screening programmes expand, most nodules found are benign, and the value of such tools lies in reducing unnecessary procedures without delaying cancer diagnoses.","status":"approved","asOf":"2026-09-10","links":[{"label":"Optellum","url":"https://optellum.com"}],"tags":["test"],"related":["sybil"],"cancers":["nsclc"],"sections":[],"technologies":["radiology-ai-screening","low-dose-ct-screening","ct"],"targets":[],"drugs":[],"companies":["optellum"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a low malignancy score supports watchful CT follow-up of a nodule; a high score speeds up PET scan or biopsy."],"brand":"Virtual Nodule Clinic","modality":"AI lung nodule malignancy prediction software (CT)","mechanism":"Deep-learning Lung Cancer Prediction (LCP) score on CT images of indeterminate pulmonary nodules, combined with nodule tracking software to support clinic decision-making.","approvals":[{"region":"US","year":2021,"indication":"510(k) clearance: AI decision support for indeterminate pulmonary nodules"},{"region":"EU","year":2020,"indication":"CE mark"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/optellum-virtual-nodule-clinic/","neighbours":{"technology":[{"id":"radiology-ai-screening","kind":"technology","name":"AI in radiology","route":"/technologies/radiology-ai-screening/"},{"id":"ct","kind":"technology","name":"CT (computed tomography)","route":"/technologies/ct/"},{"id":"low-dose-ct-screening","kind":"technology","name":"Low-dose CT lung screening","route":"/technologies/low-dose-ct-screening/"},{"id":"sybil","kind":"technology","name":"Sybil (MIT/MGH lung cancer risk from CT)","route":"/technologies/sybil/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"company":[{"id":"optellum","kind":"company","name":"Optellum","route":"/companies/optellum/"}],"term":[{"id":"pulmonary-nodule","kind":"term","name":"Pulmonary nodule","route":"/terms/pulmonary-nodule/"}]}}