Case Study: IMIDEX improves lung nodule detection and achieves FDA clearance with V7 Darwin

How IMIDEX uses V7 to Detect Pulmonary Nodules, Indicative of Lung Cancer

IMIDEX, a Denver-based healthcare company, is on a mission to save lives lost to lung cancer by using AI to detect pulmonary nodules and masses in chest X-rays. To reach FDA clearance for its VisiRad XR product, IMIDEX needed a platform that could support rigorous clinical studies, handle large DICOM datasets, and coordinate multiple users across the US with precise, compliant labeling workflows.

IMIDEX used V7 Darwin to annotate chest X-rays, run custom workflows with consensus and blind reads, and manage quality assurance for both training data and multi-site clinical validation studies. With V7, the team improved model accuracy and successfully achieved FDA 510(k) clearance in August 2023; VisiRad XR reached 83% sensitivity, nearly 30% higher than radiologists in regular practice, and IMIDEX estimates it could help identify up to 1.3 million additional lung nodules or masses annually in the US.

IMIDEX

Raj Chopra

Chief Medical Officer