FDA Clears Optellum’s Lung Cancer Clinical Decision-Support Software

March 25, 2021

The FDA has granted Optellum 510(k) clearance for its Virtual Nodule Clinic, an artificial intelligence (AI)-based software product for identifying early-stage lung cancer.

The software helps pulmonologists track at-risk patients who have suspicious lung nodules that may indicate early-stage cancer. It uses a Lung Cancer Prediction score that enables physicians to evaluate the risk of lung cancer and informs their clinical decisions. The score is generated from images captured by standard computed tomography scanners.

According to the Oxford, England-based company, the Virtual Nodule Clinic is the first AI-powered decision-support software for lung cancer that has been cleared by the FDA.

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