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 is computed from patterns of 3D pixels in images captured by CT scanners.
“We are delighted to launch the world’s first AI-based decision support for early lung cancer diagnosis cleared by the FDA,” Optellum co-founder & CEO Václav Potěšil said in the release. “This clearance 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 physicians and AI working together – to the benefit of patients.
“Our goal at Optellum is to redefine early diagnosis and treatment of lung cancer, and this FDA clearance is the first step on that journey. We look forward to empowering clinicians in every hospital, from our current customers at academic medical centers to local community hospitals, to offer patients with lung cancer and other deadly lung diseases the most optimal diagnosis and treatment.”