Optellum today announced that it has received 510 (k) clearance from the FDA for its Virtual Nodule Clinic for the Early Diagnosis of Lung Cancer.
The product from Optellum, based in Oxford, England, is an AI-based clinical decision support software system for pulmonologists and radiologists who care for patients with nodules (small lesions) in the lungs. lungs that could represent early-stage lung cancer, according to a press release.
The company is promoting its offering as the first AI decision support app for early diagnosis of lung cancer that has been approved by the FDA.
Optellum’s Virtual Nodule Clinic enables 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 Score (LCP) designed to provide more accurate and consistent lung cancer risk assessments. Optellum’s LCP score is powered by the Radiomics digital biomarker and is calculated from 3D pixel patterns in images captured by CT scanners.
“We are delighted to launch the world’s first AI-based decision support tool for the early diagnosis of lung cancer cleared by the FDA,” Optellum co-founder and CEO Václav Potěšil noted in the output. “This clearance will ensure clinicians 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 – for the benefit of patients.” .
“Our goal at Optellum is to redefine the early diagnosis and treatment of lung cancer, and this FDA clearance is the first step on that journey. We look forward to enabling clinicians in every hospital, from our current clients in academic medical centers to local community hospitals, to provide patients with lung cancer and other fatal lung diseases the most optimal diagnosis and treatment.
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