Optellum, a leading lung health company focusing on redefining early lung disease diagnosis as well as treatment, has reportedly announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its proprietary clinical decision support software, Virtual Nodule Clinic.
According to Optellum, this innovative, new product is an AI-based clinical decision support software that would help radiologists and pulmonologists in managing patients that are suffering from small lesions, called nodules, in their lungs, which could hint towards early-stages of lung cancer.
According to reports, the Virtual Nodule Clinic (VNC) is the first of its kind AI-powered software, that provides decision support to medical professionals for early-stage lung cancer diagnosis, that has been cleared by the FDA.
As per official estimates, lung cancer is responsible for killing more people annually than any other type of cancer. In fact, the existing five-year survival rate for lung cancer is an abysmal 20%, which is primarily owing to the fact that a majority of the patients are diagnosed far after disease symptoms have started to appear and the cancer has progressed to the advanced stage.
In comparison, the overall survival rate for relatively small tumors that are treated at Stage IA is approximately up to 90%. Earlier this month, the USPSTF (United States Preventive Services Task Force), updated the screening recommendations they provide with a specific push towards diagnosis of lung cancer at its early stage, when it is significantly more responsive to treatment.
Optellum’s VNC is specifically designed to effectively solve the challenge of early diagnosis by allowing pulmonologists to correctly identify as well as track patients that are at-risk and have developed suspicious lung nodules, and take optimal medical decisions for these patients.
The new software also features an LCP (Lung Cancer Prediction) score that is clinically-validated and designed to enable clinicians to evaluate lung cancer risk more consistently and accurately while also making optimal clinical decisions to save patient lives.
Optellum CEO and co-founder, Vaclav Potesil, Ph.D., stated that the FDA clearance is just the first step, and that Optellum intends to redefine early lung cancer diagnosis as well as treatment as a whole.