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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.
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.
Deep-learning Lung Cancer Prediction (LCP) score on CT images of indeterminate pulmonary nodules, combined with nodule tracking software to support clinic decision-making.
1.Optellum Virtual Nodule Clinic slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2021 | 510(k) clearance: AI decision support for indeterminate pulmonary nodules |
| EU | 2020 | CE mark |
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Shares AI in radiology and the tag test.
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