Case Study: IMIDEX detects lung nodules and gains FDA clearance with V7 Darwin

IMIDEX boosts lung nodule detection by 83% sensitivity with V7

IMIDEX, a healthcare company focused on AI-driven lung cancer detection, needed to achieve FDA clearance for its nodule detection technology. This required generating vast, high-quality datasets of annotated chest X-rays and executing complex multi-site clinical studies. The challenge involved navigating strict medical regulations and managing a remote team of annotators, all while needing a platform with robust DICOM support and airtight quality assurance workflows. IMIDEX turned to V7 and its Darwin platform to meet these rigorous training data needs.

Using V7, IMIDEX annotated chest X-rays and executed the clinical validation studies necessary for FDA approval. The solution's custom workflows, DICOM tools, and annotation tracking enabled the team to generate the high-quality ground truth data required to train their model, VisiRad XR. As a result, IMIDEX's flagship product received FDA 510(k) clearance, demonstrating a sensitivity of 83% for detecting lung nodules—nearly 30% greater than radiologists achieve in regular practice. V7 helped IMIDEX build a tool estimated to identify up to 1.3 million additional lung nodules annually, contributing to earlier cancer detection and better patient outcomes.

IMIDEX