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-powered clinical decision support software system for pulmonologists and radiologists who manage patients with nodules (small lesions) in the lungs that could represent early-stage lung cancer, according to a press release.
The company touts its offering as the first application of this type of AI-based decision support 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 make optimal clinical management decisions.
The software includes a clinically validated Lung Cancer Prediction (LCP) score designed to provide more accurate and consistent lung cancer risk assessments. The Optellum LCP score is powered by the Radiomics digital biomarker and is calculated from 3D pixel patterns in images captured by CT scanners.
“We are excited to launch the world’s first AI-based decision support for early diagnosis of lung cancer, approved by the FDA”, co-founder and CEO of Optellum, Václav Potěšil noted in the release. “This authorization will ensure clinicians have the clinical decision support they need to diagnose and treat lung cancer at the earliest possible stage, harnessing the power of doctors 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 in that journey. We look forward to empowering clinicians in every hospital, from our current customers in academic medical centers to local community hospitals, with the means to provide patients with lung cancer and other life-threatening lung diseases with the most optimal.