Optellum wins CE mark for AI-powered early lung cancer diagnostic tech

[Image from Optellum]Optellum announced that it received CE mark for its artificial intelligence (AI)-powered Virtual Nodule Clinic software platform.

Oxford, England-based Optellum designed the Virtual Nodule Clinic as a clinical decision-support tool for helping clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous. The platform received FDA 510(k) clearance in March 2021.

Since receiving FDA clearance, Optellum has received support through partnerships with the National Health Service (NHS) with funding from Innovate UK and the National Institute for Health Research (NIHR), culminating in the European approval, according to a news release.

The Virtual Nodule Clinic integrates the clinically validated Lung Cancer Prediction (LCP) score based on imaging AI. Optellum said it has the potential to improve clinical care coordination and decisions with the intention of getting patients treated before…

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FDA clears Optellum AI-based software system for early lung cancer diagnosis

Optellum announced today that it received FDA 510(k) clearance for its Virtual Nodule Clinic for early lung cancer diagnosis.

Oxford, England-based Optellum’s product is an AI-powered clinical decision support software system for pulmonologists and radiologists managing patients with nodules (small lesions) in the lungs that could represent early-stage lung cancer, according to a news release.

The company touts its offering as the first such application of AI decision support for early lung cancer diagnosis that was cleared by the FDA.

Optellum’s Virtual Nodule Clinic allows pulmonologists to identify and track at-risk patients with suspicious lung nodules and to make optimal clinical management decisions.

The software includes a clinically validated lung cancer prediction (LCP) score designed to offer more accurate and consistent lung cancer risk evaluations. Optellum’s LCP score is powered by the Radiomics digital biomarker and…

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