Lung health company Optellum has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) based clinical decision support software for early lung cancer diagnosis.

Virtual Nodule Clinic, which is an AI-based clinical decision support software, will help pulmonologists and radiologists managing patients with small lesions in the lungs called nodules that may represent early-stage lung cancer.

It is claimed to be the first of its kind software approved by the FDA for early lung cancer diagnosis.

Optellum co-founder and CEO Dr Václav Potěšil said: “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.”

Optellum has designed the AI-based software to help pulmonologists detect and track at-risk patients with suspicious lung nodules and make optimal clinical management decisions for the patients.

The software includes a clinically-validated Lung Cancer Prediction (LCP) score, which will help clinicians to precisely and consistently assess lung cancer risk.

Optellum’s LCP score is said to be supported by the world’s first FDA-cleared imaging AI/”Radiomics”-based digital biomarker for lung cancer.

The score is computed from full patterns of 3D pixels in standard images acquired by computed tomography (CT) scanners.

According to the company, the clinical study that supported the FDA clearance demonstrated a statistically significant improvement in their accuracy for diagnosing lung nodules when using the firm’s AI-based software.