Optellum Virtual Nodule Clinic
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.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | 510(k) clearance: AI decision support for indeterminate pulmonary nodules |
| EU | 2020 | CE mark |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"Optellum Virtual Nodule Clinic" OR ABSTRACT:"Optellum Virtual Nodule Clinic" OR TITLE:"Virtual Nodule Clinic" OR ABSTRACT:"Virtual Nodule Clinic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Optellum Virtual Nodule Clinic, not a curated reading list.
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